更新于：2024-12-06
Acotiamide Hydrochloride Hydrate
盐酸阿考替胺
更新于：2024-12-06
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 日本 (2013-03-25), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构
分子式C21H37ClN4O8S |
InChIKeyNPTDXIXCQCFGKC-UHFFFAOYSA-N |
CAS号773092-05-0 |
关联
51
项与 盐酸阿考替胺 相关的临床试验A Randomized, Placebo-Controlled, Double-Blind, Crossover Comparative Study of the Effect of Acotiamide on Gastrointestinal Symptoms in Patients with Myasthenia Gravis - ACTMG
盐酸阿考替胺片在中国健康人群中单次给药的人体生物等效性临床试验
Randomized placebo controlled single blind study of the effectiveness of ACOTIAMIDE in functional dyspepsia
100 项与 盐酸阿考替胺 相关的临床结果
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100 项与 盐酸阿考替胺 相关的转化医学
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100 项与 盐酸阿考替胺 相关的专利（医药）
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124
项与 盐酸阿考替胺 相关的文献（医药）2024-09-28Cureus Journal of Medical Science
Long-Term Vonoprazan and Acotiamide-Refractory Patients With Functional Dyspepsia Partly Exhibit Pancreatic Enzyme Abnormalities
Article
作者: Ueki, Nobue ; Iwakiri, Katsuhiko ; Futagami, Seiji ; Kawawa, Rie ; Onda, Takeshi ; Higashida, Sakura ; Nakamura, Ken ; Habiro, Mayu ; Agawa, Shuhei
BACKGROUND:
Although a new potassium-competitive acid blocker (P-CAB) vonoprazan has been developed in Japan, no data are available regarding long-term vonoprazan or vonoprazan and acotiamide combination treatment in patients with functional dyspepsia (FD).
METHODOLOGY:
A total of 73 consecutive patients with FD diagnosed according to the Rome III classification were enrolled. Forty-two patients with FD were treated with vonoprazan monotherapy and thirty-one patients with FD were treated with vonoprazan and acotiamide combination therapy for 24 weeks. The levels of five pancreatic enzymes were measured, and the overall treatment efficacy (OTE) was defined as the ratio of FD patients with improved or unchanged in all items of GSRS and FD symptom scores after the treatment.
RESULTS:
Treatment with vonoprazan monotherapy and vonoprazan and acotiamide combination therapy significantly improved FD symptoms. There were no significant differences in OTE between patients treated with vonoprazan monotherapy (42.9%) and those treated with vonoprazan and acotiamide combination therapy (52%). There were no significant differences in duodenal eosinophilic infiltration between the improved and unimproved groups treated with vonoprazan alone and vonoprazan and acotiamide combination therapy, respectively. In contrast, there was a significant difference (P = 0.004) in the ratio of pancreatic enzyme abnormalities between the improved and unimproved patients treated with vonoprazan monotherapy and those treated with vonoprazan and acotiamide combination therapy.
CONCLUSIONS:
Long-term vonoprazan alone or vonoprazan and acotiamide combination therapy significantly improved each FD symptom. The OTE in patients treated with vonoprazan alone or vonoprazan and acotiamide combination therapy was only 50%. Long-term vonoprazan and acotiamide combination therapy may differentiate patients with pancreatic enzyme abnormalities from those with FD.
2023-10-31BMC gastroenterology
Prokinetics for the treatment of functional dyspepsia: an updated systematic review and network meta-analysis.
Review
作者: Li, Yanqing ; Liu, Han ; Wang, Nana ; Qi, Qingqing
BACKGROUND:
Since the previous network meta-analysis assessing the efficacy of prokinetics for functional dyspepsia (FD), there have been a number of new studies and cinitapride is a new prokinetic agent for FD. This updated meta-analysis aimed to explore the efficacy and safety of prokinetics for FD.
METHODS:
An updated study search in Pubmed, EMBASE, Cochrane Library and Web of Science was conducted in literatures published from July 2015 to March 2023. Randomized controlled trials investigating the use of prokinetics in adult FD patients were included. The primary outcome was the total efficacy rate and the secondary outcome was adverse events. A Bayesian network meta-analysis was performed using R software.
RESULTS:
A total of 28 studies were included. Network meta-analysis showed that metoclopramide had a higher total efficacy rate than mosapride (OR: 3.53, 95%CI: 1.70-7.47), domperidone (OR: 2.29, 95%CI: 1.16-4.63), itopride(OR: 2.77, 95%CI: 1.41-5.59), acotiamide(OR: 2.63, OR: 1.33-5.36), and placebo(OR: 5.68, 95%CI: 2.98-11.10), however similar to cinitapride (OR: 1.62, 95%CI: 0.75-3.53). Cinitapride had a higher total efficacy rate than mosapride (OR: 2.18, 95%CI: 1.16-4.14) and placebo (OR: 3.52, 95%CI: 2.01-6.24). Cinitapride had lower risk of total adverse events than domperidone. There was no difference in the risk of drug-related adverse events between the prokinetics.
CONCLUSIONS:
Metoclopramide and cinitapride may have a better efficacy than other prokinetics in the treatment of FD, and cinitapride may have a lower risk of total adverse events. Further studies using uniform definitions or validated tools to measure the total efficacy rate are needed.
2023-07-18Trials
Evaluating the efficacy and safety of acotiamide in patients with esophagogastric junction outflow obstruction: study protocol for an investigator-initiated, multi-center, randomized, double-blind, placebo-controlled phase II trial.
Article
作者: Ogawa, Yoshihiro ; Manabe, Noriaki ; Suzuki, Maya ; Akiyama, Junichi ; Watanabe, Hiroko ; Misumi, Akiko ; Kishimoto, Junji ; Kawami, Noriyuki ; Esaki, Mitsuru ; Uraoka, Toshio ; Chinen, Takatoshi ; Ihara, Eikichi ; Ogino, Haruei ; Kuribayashi, Shiko ; Iwakiri, Katsuhiko
BACKGROUND:
We have determined that the impaired accommodation of the lower esophageal sphincter (LES) underlies the pathogenesis of esophagogastric junction outflow obstruction (EGJOO). We have also found that acotiamide may treat EGJOO by improving impaired LES accommodation. The effects of acotiamide in patients with EGJOO need to be further confirmed in a prospective study.
METHODS:
This trial is a multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of acotiamide (300 mg/day or 600 mg/day) with those of a placebo in the treatment of patients with EGJOO. The primary endpoint will be the proportion of patients who report an improvement in symptom of food sticking in the chest after 4 weeks of treatment period 1. The secondary endpoints will be the proportion of patients with normalized integrated relaxation pressure (IRP), the value of change from baseline in the distal contractile integral, basal LES pressure, EGJOO-quality of life score, Gastrointestinal Symptom Rating Scale, and the correlation between IRP and each symptom score. During the 2-year trial period, 42 patients from five institutions will be enrolled.
DISCUSSION:
This trial will provide evidence to clarify the efficacy and safety of acotiamide as a treatment for patients with EGJOO. Acotiamide might help improve the quality of life of patients with EGJOO and is expected to prevent the progression of EGJOO to achalasia.
TRIAL REGISTRATION:
This study was approved by the Institutional Review Board (IRB) of Kyushu University Hospital as well as the local IRBs of the participating sites for clinical trials and registered in the Japan Registry of Clinical Trials (jRCT: 2071210072). The registration date is on October 11, 2021.
100 项与 盐酸阿考替胺 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 消化不良 | 日本 | 2013-03-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 恶心 | 临床2期 | 美国 | 2004-03-10 | |
| 膀胱功能不全 | 临床2期 | - | - |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | (Patients with EGJOO) | 糧鬱夢積觸築選顧鬱廠(餘簾範顧夢餘淵製襯網) = Acotiamide was administered to address severe symptoms in six out of 13 patients with EGJOO. Acotiamide normalized impaired receptive LES relaxation and substantially improved symptoms. 遞廠選廠築衊蓋淵糧餘 (蓋廠鏇築餘夢繭鏇簾蓋 ) | - | 2016-10-01 | ||
(Normal subjects) | |||||||
N/A | - | Acotiamide 10 mg thrice daily | 襯齋鑰鑰鬱醖蓋憲簾築(襯夢膚構廠糧廠壓積廠) = 觸膚鬱夢齋廠製鹽夢範 製獵淵顧獵鏇衊簾獵範 (蓋壓範獵窪壓鏇鏇廠淵 ) | - | 2016-10-01 | ||
Placebo | 襯齋鑰鑰鬱醖蓋憲簾築(襯夢膚構廠糧廠壓積廠) = 鏇壓鏇鹽範繭衊觸醖廠 製獵淵顧獵鏇衊簾獵範 (蓋壓範獵窪壓鏇鏇廠淵 ) | ||||||
N/A | 50 | 繭壓壓衊積獵獵夢齋範(鑰製醖選築築鑰廠鹹鬱) = 觸壓鏇糧鑰餘網衊築網 襯鏇遞衊鹽獵築鏇築鹹 (夢製糧憲構築壓願鏇鬱 ) 更多 | 积极 | 2016-10-01 | |||
Placebo | 繭壓壓衊積獵獵夢齋範(鑰製醖選築築鑰廠鹹鬱) = 願醖窪繭醖繭齋鏇餘範 襯鏇遞衊鹽獵築鏇築鹹 (夢製糧憲構築壓願鏇鬱 ) 更多 | ||||||
临床3期 | - | 積網夢齋願製鬱廠糧繭(憲膚窪選鏇鏇範選壓製) = 鬱鏇餘醖製鏇選簾蓋選 鑰鹽繭壓鑰糧繭顧繭鏇 (壓壓憲願醖夢觸鹹鑰餘 ) | 积极 | 2012-06-01 | |||
Placebo | 積網夢齋願製鬱廠糧繭(憲膚窪選鏇鏇範選壓製) = 顧網鏇艱蓋鑰鹹窪艱蓋 鑰鹽繭壓鑰糧繭顧繭鏇 (壓壓憲願醖夢觸鹹鑰餘 ) |
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