CTRI/2025/06/088463尚未招募不适用
A post approval observational study to assess the impact for fixed dose CombinatiOn of trypsin, chyMotrypsin, Aceclofenac, Paracetamol for MinOr SurgEries (COMPOSE II)
Torrent Pharmaceuticals Ltd6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Visual analogue scale (VAS) for pain, inflammation and/or swelling assessed at 24 hrs. Day 3 and Day 7 (± 2
研究概览
简要总结
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of equal to and greater than 18 years Treatment naïve patients with Orthopedic surgery General surgery and Soft tissue injuries requiring Debridement which qualify for NSAID plus oral enzyme combination at discretion of physician.
排除标准
- •Patients treated with gabapentanoids pregabalin gabapentin for neuropathic pain Cases with hepatic enzyme elevation of 5xULN or CKD with proteinuria greater than Stage 3 Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) Hypersensitivity reactions (eg.
- •Asthma rhinitis angioedema or urticaria) in response to ibuprofen aspirin or other non-steroidal anti-inflammatory drugs Uncontrolled status for congestive heart failure (NYHA II-IV) ischaemic heart disease peripheral arterial disease and/or cerebrovascular disease History of gastrointestinal bleeding or perforation related to previous NSAIDS therapy Active bleedings or bleeding disorders Hypersensitivity to trypsin-chymotrypsin paracetamol Aceclofenac or any of the other constituents Pregnancy and Lactation Patients who have any condition or medicine that in the opinion of the investigator did not the justify their inclusion in the study.
结局指标
主要结局
Visual analogue scale (VAS) for pain, inflammation and/or swelling assessed at 24 hrs. Day 3 and Day 7 (± 2
时间窗: at 24 hrs. Day 3 and Day 7 (± 2 | days)
days)
时间窗: at 24 hrs. Day 3 and Day 7 (± 2 | days)
次要结局
- Functional assessment scale score for impact on Personal care Daily activities Sleep and Affected area or limb(movement assessment at 24 hrs. and Day 3 and Day 7 (± 2 days))
研究者
Dr Sanjay B Londhe
Nanavati super speciality Hospital
研究点 (6)
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