Diabetes is a chronic disease that affects a large part of the United States population. The majority of patients with diabetes will experience gastrointestinal symptoms. One of the most troublesome gastrointestinal symptoms that diabetes can cause is diarrhea, otherwise known as "Diabetic Diarrhea." This occurs because diabetes does damage to nerves that control the gut and prevent it from functioning normally. Currently, there are only several medications used to treat the symptoms of Diabetic Diarrhea, but many of these medications have serious side effects or do not work well.
We are investigating the drug eluxadoline for the treatment of Diabetic Diarrhea. Eluxadoline is a gut-specific medication that is FDA approved to treat diarrhea related to irritable bowel syndrome (IBS-D). Our hypothesis is eluxadoline will safely and successfully reduce diarrhea symptoms (number of stools and less liquid stools) and improve the quality of life in patients with Diabetic Diarrhea when compared with placebo. Each patient with Diabetic Diarrhea who participates will take both eluxadoline and a placebo drug at separate times over a period of several months as part of a crossover study design. While on each medication, eluxadoline or placebo, the participants will keep a diary of symptoms and will be followed by the medical team through a combination of office visits and questionnaires. There will be five planned office visits and intermittent phone calls (questionnaires, surveys) over the 140-day study period. Participants will not be permitted to use any other anti-diarrhea medication during the study period and will continue on medication for management of their diabetes.

开始日期2022-07-01

申办/合作机构

Temple University Graduate School

[+1]

NCT04880876

/ Enrolling by invitation临床3期

A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.

开始日期2021-08-13

申办/合作机构

AbbVie, Inc.

NCT03489265

/ Withdrawn临床2期IIT

Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline

Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is difficult to find a dose that does not cause constipation, and it does not reduce urge sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline.
The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally twice a day will reduce the average number of days the patient has accidental bowel leakage, and to see if the rate of accidental bowel leakage increases when the patient stops taking eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge sensations.
This is a small (pilot) study to show whether eluxadoline is an effective way of treating accidental bowel leakage. If the study shows this, a larger study will be needed. There are three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when you stop taking eluxadoline.
To participate in the study, patients should be aged 18 or older. Patients with inflammatory bowel disease, anal fissures, or congenital malformations will be excluded.
The primary outcome is the average number of days per week with any solid or liquid bowel accidents. Additional information includes: (1) Number of days per week the patient takes loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the study.

开始日期2019-04-01

申办/合作机构

The University of North Carolina at Chapel Hill

[+1]

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100 项与艾沙度林相关的转化医学

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项与艾沙度林相关的文献（医药）

2025-03-04·Expert Review of Gastroenterology & Hepatology

An evidence-based update on the diagnosis and management of irritable bowel syndrome

Review

作者: Black, Christopher J. ; Ford, Alexander C.

INTRODUCTION:

Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction affecting 5% of the population. The cardinal symptoms are abdominal pain and altered stool form or frequency.

AREAS COVERED:

Diagnosis and management of IBS. We searched the literature for diagnostic accuracy studies, randomized controlled trials, and meta-analyses. A positive diagnosis of IBS, alongside testing to exclude celiac disease, is recommended. Exhaustive investigation has a low yield. Patients should be offered traditional dietary advice. If response is incomplete, specialist dietetic guidance should be considered. Probiotics may be beneficial, but quality of evidence is poor. First-line treatment of constipation is with laxatives, with secretagogues used where these are ineffective. Anti-diarrheal drugs should be used first-line for diarrhea, with second-line drugs including 5-hydroxytryptamine-3 antagonists, eluxadoline, or rifaximin, where available. First-line treatment of abdominal pain should be with antispasmodics, with gut-brain neuromodulators prescribed second-line. Low-dose tricyclic antidepressants, such as amitriptyline, are preferred. Brain-gut behavioral therapies are effective and have evidence for efficacy in patients refractory to standard therapies.

EXPERT OPINION:

Despite substantial advances, there remains scope for improvement in terms of both the diagnosis and management of IBS. Reinforcement of positive diagnostic strategies for the condition and novel treatment paradigms are required.

2024-09-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

A multi-analyte assay of opioids in API and drug products using HPLC and HRMS

Article

作者: Ngo, Diem ; Geerlof-Vidavsky, Ilan ; Gryniewicz-Ruzicka, Connie ; Stark, Matthew ; Balch, Maurie

Surveillance testing is an essential component to ensuring safe, effective, and high-quality drug products are available in the commercially marketed US supply chain. Surveillance allows the agency to assess product quality and monitor for potential adulteration of drug products being used by consumers. Opioid drug products can be adulterated to enhance the effect of the intended active ingredient. Numerous accounts have been reported where fentanyl has been used as an adulterant in illicit street drugs such as heroin, cocaine, or methamphetamine. To efficiently surveil the legitimate opioid supply chain, an analytical method with the ability to simultaneously detect, identify and quantify opioid molecules is desired. In this study, a multi-opioid protocol (MOP) using liquid chromatography-high resolution mass spectrometry (HPLC-HRMS) technology was developed and validated for the detection and quantification of 27 opioid drugs. The MOP analytical procedure was applied to the analysis of drug substance and finished dosage forms. MOP was used to identify and quantify active pharmaceutical ingredients (API) listed on the label claim, and in the case of suspected economically motivated adulteration could identify and quantify undeclared opioid APIs. The analytical method analysis time was 16 minutes and the LOD and LOQ in full MS mode were (average) 0.3 and 0.8 ng/mL, respectively. The validation criteria parameters were satisfactory based on international guidelines (ICH). The MOP was successfully applied to the analysis of over 160 drug substances and finished products. For all samples tested in the study, their identities were confirmed, and assays met specifications. Overall, there was no evidence of illegal substitution or adulteration in any of the ingredients and products tested from the legitimate commercial marketed US supply chain.

2024-06-01·Advances in therapy

Treatment-Free Interval: A Novel Approach to Assessing Real-World Treatment Effectiveness and Economic Impact Among Patients with Irritable Bowel Syndrome with Diarrhea

Article

作者: Guérin, Annie ; Dashputre, Ankur A ; Lacy, Brian E ; Heimanson, Zeev ; Bumpass, Brock ; Gagnon-Sanschagrin, Patrick ; Bungay, Rebecca ; Joseph, George ; Borroto, Danellys ; Bellefleur, Remi

INTRODUCTION:

Objective assessment of treatment effectiveness using real-world claims data is challenging. This study assessed treatment-free intervals (TFI) as a proxy for treatment effectiveness, and all-cause healthcare costs among adult patients with irritable bowel syndrome with diarrhea (IBS-D) treated with rifaximin or eluxadoline in the USA.

METHODS:

Adult patients (18-64 years) with IBS-D and ≥ 1 rifaximin or eluxadoline prescription were identified in the IQVIA PharMetrics^® Plus database (10/01/2015-12/31/2021) and classified into two mutually exclusive cohorts (i.e., rifaximin and eluxadoline). Index date was the date of rifaximin or eluxadoline initiation. Entropy-balanced baseline characteristics, TFI (periods of ≥ 30 consecutive days without IBS-D treatment), and healthcare costs were reported. Healthcare costs were compared between cohorts using mean cost differences.

RESULTS:

There were 7094 and 2161 patients in the rifaximin and eluxadoline cohorts, respectively. After balancing, baseline characteristics (mean age 44.1 years; female 72.4%) were similar between cohorts. A higher proportion of patients treated with rifaximin achieved a TFI of ≥ 30 days (76.2% vs. 66.7%), ≥ 60 days (67.0% vs. 47.0%), ≥ 90 days (61.0% vs. 38.7%), ≥ 180 days (51.7% vs. 31.0%), and ≥ 240 days (47.7% vs. 27.9%) compared to eluxadoline. Among patients with a TFI ≥ 30 days, mean TFI durations were 8.3 and 6.0 months for the rifaximin and eluxadoline cohorts. Mean all-cause healthcare costs were lower for rifaximin vs. eluxadoline ($18,316 vs. $23,437; p = 0.008), primarily driven by pharmacy costs ($7348 vs. $10,250; p < 0.001). In a simulated health plan of one million commercially insured lives, initiating 50% of patients on rifaximin instead of eluxadoline resulted in total cost savings of $2.1 million per year or $0.18 per-member-per-month.

CONCLUSIONS:

This real-world study suggests that TFI is a meaningful surrogate measure of treatment effectiveness in IBS-D. Patients treated with rifaximin had longer treatment-free periods and lower healthcare costs than patients treated with eluxadoline.

项与艾沙度林相关的新闻（医药）

2024-06-04

·PRNewswire

Analysis Group Researchers Suggest a Novel Approach to Measuring Real-World Treatment Effectiveness for Irritable Bowel Syndrome with Diarrhea

BOSTON, June 4, 2024 /PRNewswire/ -- Researchers from Analysis Group, a global leader in health economics and outcomes research (HEOR), have coauthored a study detailing how treatment-free intervals (TFIs) can be an effective surrogate in retrospective data analyses for understanding therapy effectiveness for conditions that present multifaceted symptoms across widely divergent patient populations, such as irritable bowel syndrome with diarrhea (IBS-D). The study, published in the journal Advances in Therapy, is the first to use TFIs to assess real-world IBS-D therapy response, using two of the most commonly prescribed treatments in the US: rifaximin and eluxadoline. While the Food and Drug Administration (FDA) recommends using a five-item opinion-based questionnaire to measure patient-reported outcomes (PROs) that capture clinically important signs and symptoms to define treatment effects in clinical trials, it is challenging to apply this method to evaluate real-world outcomes in retrospective studies. The difficulty lies in the complex presentation of IBS-D, a common, chronic, relapsing, and potentially severe disorder of gut–brain interaction characterized by troublesome symptoms such as abdominal pain, diarrhea, fecal urgency, and bloating. To overcome these challenges, study investigators analyzed US commercial claims data for 9,255 IBS-D patients receiving one of the two treatments over the course of one year. The researchers focused on patients' TFI patterns – the length of time a patient remains off treatment after a course of therapy. Patient characteristics included age, sex, health plan type, region, and provider specialty, as of the index date. During baseline, medically relevant comorbidities (both gastrointestinal- and mental health–related), procedures (e.g., anesthesia, surgery, radiation services), and treatments were reported. Investigators specifically examined the duration of the index treatment, the number of prescription fills, and all-cause health care costs among adult patients with IBS-D treated with rifaximin or eluxadoline. The researchers concluded that TFIs may be a meaningful proxy for measuring treatment effectiveness in IBS-D. Using this method, they also found that patients treated with rifaximin had longer TFIs and lower health care costs than patients treated with eluxadoline. "The challenges of studying IBS-D are similar in many ways to those faced with oncology, where important treatment goals include medication-free periods associated with symptom control, especially when there is a treatment-related toxicity or financial burden associated with treatment changes or combination therapy," said study investigator Annie Guérin, a Managing Principal with Analysis Group. "Our approach to using TFIs was based on the proven strategies used in oncology, where patients value treatment-free periods because they are associated with improved health-related quality of life." The study, "Treatment-Free Interval: A Novel Approach to Assessing Real-World Treatment Effectiveness and Economic Impact Among Patients with Irritable Bowel Syndrome with Diarrhea," was published in April in Advances in Therapy. In addition to Ms. Guérin, investigators included Vice President Patrick S. Gagnon, Associate Rebecca Bungay, and Senior Research Professional Remi Bellefleur of Analysis Group; Brian E. Lacy of Mayo Clinic; Zeev Heimanson of Salix Pharmaceuticals; Brock Bumpass, Danellys Borroto, and Ankur A. Dashputre of Bausch Health; and George Joseph of BioNTech US. Funding was provided by Bausch Health. To learn more about Analysis Group's HEOR capabilities, visit About Analysis Group's HEOR, Epidemiology & Market Access Practice Founded in 1981, Analysis Group is one of the largest international economics consulting firms, with more than 1,200 professionals across 14 offices. Analysis Group's health care experts apply analytical expertise to health economics and outcomes research (HEOR), clinical research, market access and commercial strategy, and health care policy engagements, as well as drug safety-related engagements in epidemiology. Analysis Group's internal experts, together with our network of affiliated experts from academia, industry, and government, provide our clients with exceptional breadth and depth of expertise and end-to-end consulting services globally. Contact: Analysis Group Eric Seymour, +1 978 273 6049 [email protected] SOURCE Analysis Group

放射疗法临床结果临床研究

2023-06-07

·drugs

What Is Irritable Bowel Syndrome?

WEDNESDAY, June 7, 2023 -- People who suffer from irritable bowel syndrome (IBS) know it is a highly unpleasant chronic condition that can trigger abdominal pain, diarrhea and constipation. Here, experts will unravel the mysteries of IBS, exploring its causes, symptoms and treatments. And of course, don't forget about the role of diet. Experts will break down the best foods to eat and those to avoid for a happy gut. What is irritable bowel syndrome? According to the Mayo Clinic , irritable bowel syndrome is a common disorder targeting the gastrointestinal tract, encompassing the stomach and intestines. This chronic condition manifests through a range of distressing symptoms, including cramping, abdominal pain, bloating, excessive gas and the frustrating duo of diarrhea and constipation, which may occur individually or even simultaneously. Dealing with IBS requires a long-term management approach to address its persistent impact on daily life effectively. What causes IBS? The exact causes of irritable bowel syndrome remain uncertain, according to the National Institute of Diabetes and Digestive and Kidney Issues (NIDDK). However, experts believe that a combination of factors contributes to its development. IBS is considered a functional gastrointestinal (GI) disorder involving the intricate interaction between the brain and the gut. Here are some potential causes and factors that may play a role in IBS: Problems with brain-gut interaction. Brain and gut communication can impact the body's functioning, triggering IBS symptoms. This can include abnormal food movement through the digestive tract, resulting in changes in bowel movements, and experiencing pain even with average amounts of gas or stool in the gut. Stressful or difficult early-life events. Traumatic experiences during childhood, such as physical or sexual abuse, have been associated with an increased risk of developing IBS. Mental disorders. Conditions like depression, anxiety and somatic symptom disorder are more common among individuals with IBS and may contribute to its onset. Bacterial infections. Infections of the digestive tract caused by certain bacteria have been linked to developing IBS. Small intestinal bacterial overgrowth. In terms of increased numbers or changes in the bacterial type, an overgrowth of bacteria in the small intestine has been associated with IBS. Food intolerances or sensitivities. Some individuals with IBS may experience digestive symptoms triggered by specific foods, indicating intolerances or sensitivities to certain dietary components. The causes of IBS can vary among individuals, highlighting this condition's complexity. IBS symptoms In a recent video with Dr. Jennifer Webster , a pediatric gastroenterologist with Children’s Hospital of Philadelphia, she indicates that “the tricky thing about IBS is that there is no specific test that we can use to say 100% you have this . We do lots of testing to rule out other diseases. Similar to migraines, there isn’t a test, but we know that the pain is real and the symptoms are real.” While some studies suggest potential differences in the prevalence and severity of IBS symptoms between men and women, it is worth noting that the core symptoms are relatively similar. Here are some typical symptoms of IBS in men and women, according to Johns Hopkins Medicine : Abdominal pain or cramping. This is one of the hallmark symptoms of IBS. The pain is often described as a lower abdominal discomfort or cramping sensation that may vary in intensity. Bloating and distention. Many individuals with IBS experience bloating, a feeling of increased pressure or fullness in the abdomen. This can be accompanied by visible abdominal distention or swelling. Altered bowel habits. IBS can lead to changes in bowel movements. These changes can include diarrhea, characterized by loose or watery stools, and constipation, characterized by infrequent or difficult bowel movements. Some individuals may alternate between episodes of diarrhea and constipation. Excessive gas. Many people with IBS may notice increased gas production, leading to bloating, belching or flatulence. Urgency or an incomplete bowel movement. Some individuals with IBS may experience a sense of urgency to have a bowel movement or feel as though they haven't fully emptied their bowels after a bowel movement. Mucus in the stool. In some cases, people with IBS may notice the presence of mucus in their stool. Can a specific diet for IBS help with symptoms? When managing symptoms of IBS, changing your diet can play a significant role. Here are some common dietary recommendations for individuals with IBS: The NIDDK suggests the following foods to eat with irritable bowel syndrome : Increase fiber intake. Focus on incorporating sources of soluble fiber, such as oats, bananas, carrots and psyllium husk, into your diet. Avoid gluten. Avoiding gluten-containing grains like wheat, barley and rye may be beneficial for individuals with gluten sensitivity or celiac disease. Opt for gluten-free alternatives like quinoa, rice and gluten-free oats. Follow a low-FODMAP diet. Following a special diet known as the low- FODMAP diet may provide relief for some individuals with IBS. This diet for IBS involves temporarily restricting certain high-FODMAP foods, such as onions, garlic, wheat and fruits such as apples, cherries, nectarines, pears and watermelon, or juice containing any of these fruits, then gradually reintroducing them to identify specific triggers. IBS treatments The treatment of IBS aims to alleviate symptoms, allowing individuals to live as symptom-free as possible. Depending on your symptoms, your health care provider may recommend different approaches on how to treat your IBS, including medication and IBS self-care strategies. Here are some commonly prescribed irritable bowel syndrome medications as indicated by the Mayo Clinic: Alosetron (Lotronex). This medication is designed to relax the colon and slow down the movement of waste through the lower bowel. It is primarily prescribed for severe cases of IBS in women and is not approved for use in men. Eluxadoline (Viberzi). Eluxadoline is a medication that aids in reducing diarrhea by decreasing fluid secretion and muscle contractions in the intestine while simultaneously enhancing muscle tone in the rectum. Rifaximin (Xifaxan). This antibiotic decreases bacterial overgrowth in the gut and relieves diarrhea symptoms. Lubiprostone (Amitiza). Lubiprostone increases fluid secretion in the small intestine, aiding in the passage of stool. It is approved for women with IBS with constipation. Linaclotide (Linzess). Linaclotide also increases fluid secretion in the small intestine to facilitate bowel movements. Living with IBS Living with IBS can be challenging, but there are ways to manage its symptoms and improve your quality of life. Working closely with health care professionals allows you to explore dietary modifications, medication options and self-care strategies tailored to your needs. Posted June 2023

上市批准

2022-06-24

·PRNewswire

Irritable Bowel Syndrome Treatment Market to Surpass US$ 3,902.9 Million by 2030 - Coherent Market Insights

SEATTLE, June 24, 2022 /PRNewswire/ -- According to Coherent Market Insights, the global irritable bowel syndrome treatment market is estimated to be valued at US$ 1,444.7 million in 2022 and is expected to exhibit a CAGR of 13.2% during the forecast period (2022-2030). Key Trends and Analysis of the Global Irritable Bowel Syndrome Treatment Market: Major players operating in the market are focusing on conducting workshops to create awareness regarding irritable bowel syndrome, which is expected to drive the market growth over the forecast period. For instance, in May 2018, Allergan plc, a subsidiary of AbbVie Inc., a biopharmaceutical company, and Ironwood Pharmaceuticals, Inc., a healthcare company, announced the launch of the AboutYourGut.com website. The aim of this launch was to help educate sufferers impacted by irritable bowel syndrome with diarrhea (IBS-D), irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), including providing information on condition management. Request Sample Copy of this Report @ Key Market Takeaways: The global irritable bowel syndrome treatment market is expected to exhibit a CAGR of 13.2% during the forecast period due to the increasing adoption of inorganic strategies such as agreements by the key players in the market. For instance, in May 2021, Ironwood Pharmaceuticals, Inc., a healthcare company, and its partner AbbVie Inc., a biopharmaceutical company, reached an agreement with Teva Pharmaceuticals USA, Inc., a multinational pharmaceutical company. As per the terms of this agreement, Teva Pharmaceuticals USA, Inc., would be granted a license to market its 72 mcg generic version of LINZESS, the first prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), in the U.S. beginning March 31, 2029 (subject to U.S. FDA approval), unless certain limited circumstances, customary for settlement agreements of this nature occur. Among medical conditions, the IBS-constipation segment is expected to dominate the segment growth over the forecast period, owing to the increased research and development activities by the key players in the market. For instance, in May 2021, 4D pharma plc., a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, announced positive data from its completed Phase II trial of LBP Blautix, a single strain live biotherapeutic product (LBP), in subjects with irritable bowel syndrome with constipation (IBS-C) or with diarrhea (IBS-D). On the basis of drug type, the Linaclotide segment is expected to dominate the segment growth over the forecast period, owing to the increasing approvals for linaclotide. For instance, in August 2021, Ironwood Pharmaceuticals, Inc., a healthcare company, announced that the U.S. Food and Drug Administration (FDA) approved a revised label for LINZESS (linaclotide) based on clinical safety data that had been generated in pediatric studies. Key players operating in the global irritable bowel syndrome treatment market include Abbott, Synergy Pharma, Mallinckrodt, Bausch Health Companies Inc., Ardelyx, Astellas Pharma Inc., Novartis AG, GSK plc., Ironwood Pharmaceuticals, Inc., and Takeda Pharmaceutical Company Limited. Request for Customization @ Detailed Segmentation: Global Irritable Bowel Syndrome Treatment Market, By Drug Type: Lubiprostone Linaclotide Eluxadoline Rifaximin Alosetron Other Global Irritable Bowel Syndrome Treatment Market, By Medical Condition: IBS-constipation IBS-diarrhea Global Irritable Bowel Syndrome Treatment Market, By Distribution Channel: Hospital Pharmacies Retail Pharmacies Online Pharmacies Global Irritable Bowel Syndrome Treatment Market, By Region: North America By Country: U.S. Canada Europe By Country: U.K. Germany Italy France Spain Russia Rest of Europe Asia Pacific By Country: China India Japan ASEAN Australia South Korea Rest of Asia Pacific Latin America By Country: Brazil Mexico Argentina Rest of Latin America Middle East & Africa By Country: GCC Countries Israel South Africa Rest of Middle East & Africa Buy this Complete Report Now @ Find related trending report below: Short Bowel Syndrome Market — Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2022-2028 About Us: Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having sales office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 57 countries worldwide. We create value for clients through our highly reliable and accurate reports. We are also committed in playing a leading role in offering insights in various sectors post-COVID-19 and continue to deliver measurable, sustainable results for our clients. Contact Us: Mr. Shah Senior Client Partner – Business Development Coherent Market Insights Phone: US: +1-206-701-6702 UK: +44-020-8133-4027 Japan: +81-050-5539-1737 India: +91-848-285-0837 Email: [email protected] Website: Follow Us: LinkedIn | Twitter Logo: SOURCE Coherent Market Insights

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KEGG	Wiki	ATC	Drug Bank
D10403	艾沙度林	A07DA06	DB09272

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适应症	国家/地区	公司	日期
腹泻型肠易激综合征	欧盟	Allergan Pharmaceuticals International Ltd.	2016-09-19
腹泻型肠易激综合征	冰岛	Allergan Pharmaceuticals International Ltd.	2016-09-19
腹泻型肠易激综合征	列支敦士登	Allergan Pharmaceuticals International Ltd.	2016-09-19
腹泻型肠易激综合征	挪威	Allergan Pharmaceuticals International Ltd.	2016-09-19
肠易激综合征	美国	AbbVie, Inc.	2015-05-27

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病	临床3期	美国	Allergan UC	2022-07-01
腹泻	临床3期	美国	Allergan UC	2022-07-01
大便失禁	临床2期	-	Allergan UC	2019-04-01
肠瘘	临床2期	-	Allergan UC	2019-04-01
急迫性尿失禁	临床2期	-	Allergan UC	2019-04-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03441581 (3030-401-002, CTgov)	临床4期	腹泻型肠易激综合征 \| 胆汁酸吸收不良（BAM）	24	Eluxadoline (Eluxadoline 100 mg With BAM)	糧襯觸窪構簾範餘築衊(廠鏇餘壓艱獵淵顧網衊) = 鏇構襯鑰範範選觸齋鹽選憲夢鑰顧鹹鏇願膚網 (壓網鑰衊衊製觸構獵膚, 0.639) 更多	-	2021-05-19
				Eluxadoline (Eluxadoline 100 mg Without BAM)	糧襯觸窪構簾範餘築衊(廠鏇餘壓艱獵淵顧網衊) = 構觸壓鑰網獵鑰遞襯鏇選憲夢鑰顧鹹鏇願膚網 (壓網鑰衊衊製觸構獵膚, 0.777) 更多
NCT01130272 (CTgov)	临床2期	腹泻 \| 肠易激综合征	807	Eluxadoline (Eluxadoline 5 mg)	積糧襯鏇窪襯窪願鏇鬱 = 網淵築壓壓鬱蓋餘壓壓築蓋壓範壓鬱窪鹹窪窪 (餘窪夢範簾襯鹹鑰餘襯, 積艱餘鹽願壓鹹艱網襯 ~ 艱艱膚壓網窪淵製觸製) 更多	-	2019-10-22
				Eluxadoline (Eluxadoline 25 mg)	積糧襯鏇窪襯窪願鏇鬱 = 鬱簾襯鹹衊艱網艱廠繭築蓋壓範壓鬱窪鹹窪窪 (餘窪夢範簾襯鹹鑰餘襯, 築鬱憲鏇範簾鏇憲壓醖 ~ 遞簾遞艱夢築繭廠鑰廠) 更多
NCT02959983 (RELIEF, Pubmed \| Am J Gastroenterol) 人工标引	临床4期	腹泻 \| 肠易激综合征	346	Eluxadoline	廠獵糧淵蓋蓋醖窪鹽鑰(廠顧觸鬱糧廠淵夢窪糧) = 範糧積觸衊窪淵築鹹構壓顧築鑰構蓋醖夢夢蓋 (觸衊鹽網襯鬱艱夢憲壓 ) 更多	积极	2019-09-01
				Placebo	廠獵糧淵蓋蓋醖窪鹽鑰(廠顧觸鬱糧廠淵夢窪糧) = 鬱鏇夢壓鹽齋顧簾繭鑰壓顧築鑰構蓋醖夢夢蓋 (觸衊鹽網襯鬱艱夢憲壓 ) 更多
NCT02959983 (RELIEF, CTgov)	临床4期	腹泻型肠易激综合征 \| 腹泻	346	Eluxadoline (Eluxadoline)	醖製餘壓壓醖衊襯積糧 = 醖鏇簾觸繭築窪襯窪簾積衊憲簾鑰觸衊觸衊鹹 (醖艱壓選醖築選獵廠壓, 廠鑰蓋齋蓋範壓鏇蓋願 ~ 獵衊積願選選憲選鏇鑰) 更多	-	2019-02-15
				Placebo (Placebo)	醖製餘壓壓醖衊襯積糧 = 蓋願觸獵願齋網憲壓網積衊憲簾鑰觸衊觸衊鹹 (醖艱壓選醖築選獵廠壓, 蓋膚鹽鬱鬱鏇壓觸膚積 ~ 構簾選範繭壓醖製糧衊) 更多
NCT01553591 (CTgov)	临床3期	腹泻型肠易激综合征	1,282	Eluxadoline (Eluxadoline 75 mg)	淵廠範選衊膚糧艱膚蓋 = 淵鹹糧糧鹹夢鹽壓鏇簾憲簾鏇繭鏇鏇糧鏇醖齋 (願廠鏇遞襯糧製積獵窪, 襯鏇遞製壓網齋壓範獵 ~ 窪襯願繭獵淵積構鏇遞) 更多	-	2018-09-04
				Eluxadoline (Eluxadoline 100 mg)	淵廠範選衊膚糧艱膚蓋 = 襯餘廠製鹽淵範糧糧遞憲簾鏇繭鏇鏇糧鏇醖齋 (願廠鏇遞襯糧製積獵窪, 淵獵壓蓋構鹹鑰艱鏇網 ~ 衊鑰繭遞艱糧鏇繭淵獵) 更多
NCT01553747 (CTgov)	临床3期	腹泻型肠易激综合征	1,146	Eluxadoline (Eluxadoline 75 mg)	蓋餘鏇構顧繭網膚觸鏇 = 積壓廠窪願選範願獵衊廠遞襯艱選顧願網餘鬱 (繭積醖齋廠鹽齋襯壓遞, 壓餘鏇窪鹽製網願窪鏇 ~ 遞簾夢選醖獵願願鏇網) 更多	-	2018-07-30
				Eluxadoline (Eluxadoline 100 mg)	蓋餘鏇構顧繭網膚觸鏇 = 鏇衊齋鹹淵艱遞蓋糧蓋廠遞襯艱選顧願網餘鬱 (繭積醖齋廠鹽齋襯壓遞, 遞鏇鬱艱壓築繭鹹鑰憲 ~ 艱鏇構膚醖築觸壓餘膚) 更多
UEGW2017	N/A	腹泻型肠易激综合征	-	Eluxadoline 75 mg	築構憲醖顧築醖範網繭(膚築糧構艱簾蓋壓選網) = 淵範鑰製顧壓選窪壓淵製壓構襯範夢齋範糧窪 (構壓範醖鬱憲膚積網願 )	-	2017-10-01
				Eluxadoline 100 mg	築構憲醖顧築醖範網繭(膚築糧構艱簾蓋壓選網) = 衊夢觸築構鹽窪觸築糧製壓構襯範夢齋範糧窪 (構壓範醖鬱憲膚積網願 )
UEGW2017	N/A	肠易激综合征	-	Eluxadoline 100 mg BID	襯膚顧膚鏇鑰構衊膚築(製鬱襯範鑰夢遞廠積齋) = 淵顧鹹夢繭鏇遞網糧鹽淵糧鹽壓襯觸艱築艱範 (膚顧獵齋餘鹽繭鑰顧壓 )	-	2017-10-01
				Eluxadoline 75 mg BID	襯膚顧膚鏇鑰構衊膚築(製鬱襯範鑰夢遞廠積齋) = 壓膚範艱餘壓簾積壓鑰淵糧鹽壓襯觸艱築艱範 (膚顧獵齋餘鹽繭鑰顧壓 )
UEGW2016	N/A	腹泻型肠易激综合征	-	Eluxadoline 75 mg	鏇顧觸淵鬱鹹夢糧積醖(築鑰築築築壓鬱製衊齋) = 窪遞夢構網構鏇鹹壓鏇夢鹽遞衊願鬱遞繭襯簾 (窪夢廠襯餘襯夢鹽鏇鏇 ) 更多	-	2016-10-01
				Eluxadoline 100 mg	鏇顧觸淵鬱鹹夢糧積醖(築鑰築築築壓鬱製衊齋) = 艱廠簾鑰積醖遞壓夢鬱夢鹽遞衊願鬱遞繭襯簾 (窪夢廠襯餘襯夢鹽鏇鏇 ) 更多
NCT01553591 \| NCT01553747 (IBS-3001 and IBS-3002, Pubmed \| N Engl J Med)	临床3期	腹泻型肠易激综合征	2,427	Eluxadoline 75 mg	簾觸膚蓋選鹹醖簾選鹹(構鏇衊顧鏇膚構襯齋襯) = 餘鹹衊選膚蓋積衊製廠壓觸憲顧艱構繭構鹽壓 (鬱醖鹹醖廠選鹹觸構憲 ) 更多	-	2016-01-21
				Eluxadoline 100 mg	簾觸膚蓋選鹹醖簾選鹹(構鏇衊顧鏇膚構襯齋襯) = 壓淵齋壓鏇製淵鹹淵壓壓觸憲顧艱構繭構鹽壓 (鬱醖鹹醖廠選鹹觸構憲 ) 更多