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更新于：2024-12-31
Diclofenac Epolamine
双氯芬酸依泊胺
更新于：2024-12-31
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 法国 (2003-05-28) |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
分子式C20H24Cl2N2O3 |
InChIKeyDCERVXIINVUMKU-UHFFFAOYSA-N |
CAS号119623-66-4 |
关联
21
项与 双氯芬酸依泊胺 相关的临床试验CTR20241517
双氯芬酸依泊胺贴在中国健康受试者外用条件下单次给药的人体生物等效性临床试验
CTR20232884
双氯芬酸依泊胺贴治疗局部软组织损伤（拉伤、扭伤、挫伤）引起的疼痛的有效性和安全性多中心、随机、双盲、阳性药、安慰剂平行对照临床试验
ISRCTN59179622
Bioavailability, adhesion and tolerability study for the evaluation of Flector Unidie® medicated plaster applied once a day for 5 consecutive days to healthy volunteers
100 项与 双氯芬酸依泊胺 相关的临床结果
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100 项与 双氯芬酸依泊胺 相关的转化医学
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100 项与 双氯芬酸依泊胺 相关的专利（医药）
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51
项与 双氯芬酸依泊胺 相关的文献（医药）2023-10-01Pain and therapy
Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study.
Article
作者: Trevisan, Carlo L M ; Carraro, Andrea ; Baldari, Gemma L A
INTRODUCTION:
The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain.
METHODS:
A prospective, open-label, phase IV clinical study in adult outpatients at hospital clinic departments/general practitioner's clinics at eight sites in Italy. The primary efficacy variable was the degree of satisfaction with treatment at 72 ± 7 h after initiation of treatment, assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS) and described by classic descriptive statistics. Secondary objectives were to evaluate the analgesic effect after the first administration and over time; the time to and satisfaction with the onset of pain relief, amount of and duration of pain relief; pain intensity differences over time; and safety and tolerability. The investigator's satisfaction with the treatment was also assessed. Subjects initially took 1-2 capsules of the study treatment and then one or two soft capsules every 4-6 h according to their needs. Not more than six soft capsules were to be taken in any 24-h period.
RESULTS:
A total of 182 subjects (mean age, 56.2 years; 54.4% female) took ≥ 1 dose of DHEP capsule and were included in the full analysis set. The most common musculoskeletal conditions were arthralgia (39.0%) and low back pain (23.1%). All subjects completed the study, and 165/182 (90.7%, 95% CI 0.86, 0.95) were satisfied or very satisfied with the treatment at 72 ± 7 h after the first dose (primary efficacy variable). Similar percentages were recorded for treatment satisfaction concerning other efficacy parameters. The onset of the analgesic effect was rapid, with complete pain relief reached after a mean of 49.45 min. Investigators rated their overall treatment satisfaction as 92.9%. Treatment was well tolerated.
CONCLUSIONS:
The low-dose (12.5 or 25 mg) oral diclofenac epolamine soft capsules formulation exerted rapid, effective, and safe analgesic activity in patients with mild-to-moderate musculoskeletal pain, with subjects' overall satisfaction with treatment more than 90%.
TRIAL REGISTRATION:
EudraCT Number: 2018-004886-15 (Study 18I-Fsg08). Registered 04/09/2018.
2022-10-01Pharmaceutical research
Effect of Salt Form on Gelation and Drug Delivery Properties of Diclofenac-Loaded Poloxamer Gels for Delivery to Impaired Skin
Article
作者: Fiegel, Jennifer ; Brogden, Nicole K ; Russo, Jackson
PURPOSE:
Treating chronic wounds is a significant clinical challenge, and a topical product would be ideal for pain management. Poloxamer 407, a thermosensitive polymer, would allow an analgesic drug to be topically applied to a wound as a liquid that transitions to a gel at physiologic temperature. Using diclofenac as a model analgesic drug, our goal was to determine effects of salt form on poloxamer gelation and drug delivery from poloxamer gels applied to excised skin with impaired barrier function.
METHODS:
Gelation properties of 17% and 20% poloxamer gels loaded with 0.4 to 1.7% diclofenac sodium, potassium, epolamine, or diethylamine were evaluated rheologically. Drug release and delivery were quantified using cellulose membranes, porcine skin, and tape-stripped porcine skin.
RESULTS:
Poloxamer gelation temperature increased with higher diclofenac concentration, regardless of salt form; the magnitude of increase varied in the following order: sodium>potassium>diethylamine>epolamine. Gelation temperature differences resulting from the various counterions generally matched previously observed trends of ion-specific effects on macromolecule solubility (the Hofmeister series). Despite changes in gelation behavior, we observed minimal corresponding effects on drug release or delivery. There were no significant differences in diclofenac released or delivered through intact porcine skin over 48 h. However, in studies with impaired (tape-stripped) skin, diclofenac delivery was slowest overall with the epolamine salt.
CONCLUSION:
Varying the salt form of a model analgesic drug can impact gelation and drug delivery characteristics of poloxamer systems. Further study of the mechanisms of these changes will be important for continued development of topical poloxamer products for clinical wound care.
2022-01-01Clinical Drug Investigation
Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial
Article
作者: Ledesma, Gilbert ; Wisman, Paul P ; Jones, Clarence ; Jones, Christopher A ; Frangione, Valeria ; Hoehler, Fred K
BACKGROUND AND OBJECTIVE:
A topical formulation of diclofenac (FLECTOR diclofenac epolamine topical system (FDETS)) is approved in adults for the treatment of acute pain due to minor strains, sprains, and contusions; however, its safety and efficacy have not been investigated in a pediatric population. This study assessed the safety and efficacy of the FLECTOR (diclofenac epolamine) topical system in children.
METHODS:
This was an open-label, single-arm, phase IV study at ten USA-based family medicine or pediatric practices in children aged 6-16 years with a clinically significant minor soft tissue injury sustained within the preceding 96 h and at least moderate spontaneous pain on the Wong-Baker FACES® Pain Rating Scale. The FLECTOR topical system was applied twice daily until pain resolution or Day 14. The primary endpoint was local tolerability and systemic safety. Key secondary endpoints were diclofenac plasma concentrations and analgesic efficacy.
RESULTS:
104 patients were enrolled; 52 were 6-11 years old, and 52 were 12-16 years old (mean age 11.6 years). The maximum tolerability score experienced by any patient was 1 (faint redness). Fourteen adverse events (none serious) in nine patients (8.7%) were considered possibly treatment-related. Reduction in pain during the study was somewhat greater for patients aged 6-11 versus 12-16 years (p < 0.011). The diclofenac plasma concentration tended to be higher in the younger age group compared with older patients: 1.83 versus 1.46 ng/mL at the first assessment and 2.49 versus 1.11 ng/mL at the last assessment (p = 0.002).
CONCLUSION:
The FLECTOR topical system safely and effectively provided pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov identifier NCT02132247.
100 项与 双氯芬酸依泊胺 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 |
|---|---|---|---|
| 急性疼痛 | 美国 | 2007-01-31 |
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 |
|---|---|---|---|---|
| 挫伤 | 临床3期 | 中国 | 2023-11-15 | |
| 疼痛 | 临床3期 | 中国 | 2023-11-15 | |
| 扭伤和拉伤 | 临床3期 | 中国 | 2023-11-15 | |
| 软组织损伤 | 临床3期 | 美国 | 2021-10-31 | |
| 膝关节炎 | 临床前 | 美国 | 2022-03-22 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 658 | Placebo | 糧顧夢鑰衊鑰願顧遞糧(網壓製糧夢夢蓋壓顧願) = 糧衊願鏇壓願鬱顧膚鹹 網糧壓鏇壓築醖淵範願 (範壓壓製夢築壓網繭廠, 壓壓夢膚齋窪醖範簾遞 ~ 選餘憲顧積鹹壓遞獵選) 更多 | - | 2020-06-24 | ||
早期临床1期 | - | 12 | (Diclofenac Epolamine Patches) | 顧壓憲蓋襯鹽憲簾鑰醖(鬱觸窪構窪構網繭蓋鬱) = 衊淵艱鏇鹽構觸簾獵繭 鏇鬱鑰淵簾遞顧醖鬱鑰 (膚艱壓窪積顧觸積窪簾, 選壓醖憲鬱鑰鏇鏇襯夢 ~ 糧鬱構膚艱觸壓鬱夢淵) 更多 | - | 2020-06-16 | |
(Diclofenac Sodium Solution) | 顧壓憲蓋襯鹽憲簾鑰醖(鬱觸窪構窪構網繭蓋鬱) = 窪壓鹹衊餘窪鏇廠醖壓 鏇鬱鑰淵簾遞顧醖鬱鑰 (膚艱壓窪積顧觸積窪簾, 鬱齋製鏇築鹽觸蓋製顧 ~ 夢醖積願膚願衊糧糧簾) 更多 | ||||||
临床4期 | 104 | (Flector Patch/Age 6-11) | 襯製襯膚觸鬱願齋積艱(鏇齋醖鏇觸蓋鏇蓋鏇構) = 餘築獵繭積積壓艱觸構 壓鏇顧鏇衊艱觸廠醖網 (製繭壓網鹽夢膚顧淵鹹, 網憲餘廠繭網遞壓夢願 ~ 壓範觸鏇窪積壓積廠壓) 更多 | - | 2018-05-11 | ||
(Flector Patch/Age 12-16) | 襯製襯膚觸鬱願齋積艱(鏇齋醖鏇觸蓋鏇蓋鏇構) = 築窪鹹鹽鑰築築餘壓醖 壓鏇顧鏇衊艱觸廠醖網 (製繭壓網鹽夢膚顧淵鹹, 壓獵築壓蓋蓋構築構衊 ~ 選鹽鏇廠蓋獵繭獵積齋) 更多 |
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