CTRI/2025/07/091774招募中4 期
A 3arm Multicenter, Open label, Randomized Controlled Study Comparing FDC (Diclofenac 50mg plus Paracetamol 325 mg and Dicyclomine HCL 20 mg) and Spasmodart FDC (Fixed-dose Combination of Paracetamol IP 325 mg, Dicyclomine Hydrochloride IP 20 mg and Diclofenac Sodium IP 50 mg ), Phase-IV Clinical study to Evaluate Safety, Tolerability and Efficacy of in moderate to severe pain associated with Primary dysmenorrhoea, Gastro-intestinal colic, Renal colic, Biliary colic, Uterine colic, Spasmodic dysmenorrhoea, Backache, Surgical pain and spasm.
JUGGAT PHARMA5 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年8月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- To assess the Pain relief using Visual Analogue Scale (VAS)
研究概览
简要总结
This Phase-IV, multi-center, open-label, randomized controlled study is designed to assess the safety, tolerability, and efficacy of Spasmodart, a fixed-dose combination (FDC) of Paracetamol 325 mg, Dicyclomine Hydrochloride 20 mg, and Diclofenac Sodium 50 mg, in comparison to FDC Diclofenac 50 mg + Paracetamol 325 mg and Dicyclomine Hydrochloride 20 mg. The study targets moderate to severe pain associated with conditions such as primary dysmenorrhoea, gastrointestinal colic, renal colic, biliary colic, uterine colic, spasmodic dysmenorrhoea, backache, and surgical pain and spasm. The primary objective is to evaluate the efficacy of Spasmodart compared to the other two treatments. A total of 210 subjects will participate, with 70 subjects in each study arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex aged between 18 to 60 years
- •Subjects clinically diagnosed with moderate to severe pain (on VAS) due to Primary dysmenorrhoea, Gastro-intestinal colic, Renal colic, Biliary colic, Uterine colic, Spasmodic dysmenorrhoea, Backache, Surgical pain & spasm.
- •Subjects who are willing to comply with protocol procedures.
- •Subject who voluntary participate in the study with signed inform consent.
排除标准
- •Not willing to sign ICF
- •Subjects known, or thought to be hypersensitivity, to Paracetamol, Dicyclomine Hydrochloride, Diclofenac Sodium
- •Pregnant and lactating women
- •Subjects with a history of hypersensitivity to Paracetamol, Dicyclomine Hydrochloride, Diclofenac Sodium
- •Subjects having secondary dysmenorrhoea
- •Subjects having mild menstrual pain
- •Subjects with history of glaucoma and Myasthenia
- •Subjects with mechanical stenosis
- •Subjects with history of severe gastritis, peptic ulceration or any gastrointestinal bleeding
- •Subjects with serious underlying organic disorders
- •Subjects with paralytic ileus
- •Subjects with renal or hepatic disorders
- •Subjects with previous history of heart problems or stroke
- •Subjects with history of acute pancreatitis and biliary disorder other than colicky pain
- •Subjects with severe renal disorder
- •History or evidence of significant cardiovascular disease, any malignancy, thyroid dysfunction, epilepsy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment.
- •Participation in other clinical trials the last three months and doing study.
结局指标
主要结局
To assess the Pain relief using Visual Analogue Scale (VAS)
时间窗: 2,6,12, 24, 72, 96 hours after post dose
次要结局
- Physician’s Global evaluation through CGI-I scale(Safety and tolerability of the study drug(s) will be assessed by the Clinical & Laboratory AEs occurring during entire duration of study.)
研究者
Dr Poonam Goyal
Panchsheel Hospitals Pvt Ltd
研究点 (5)
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