CTRI/2019/12/022257已完成4 期
An Open-label, Multicentric, Non-comparative, observational, Phase-IV Clinical Trial toEvaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination ofCamylofin Dihydrochloride 50 mg and Paracetamol IP 325 mg in the treatment of PrimaryDysmenorrhoea, Colicâ€
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- The Primary objective of this Phase IV trial is to find out safety & tolerability of the product
研究概览
简要总结
Thisis a phase IV observational, multicentric, open lable, single arm, noncomparator study to evaluate the safety and efficacy of Fixed-doseCombination of Camylofin Dihydrochloride 50mg and Paracetamol IP 325mg in the treatmentof Primary Dysmenorrhoea, which is an oral tablet.TheFDC is to be taken thrice daily for 4 days. The evaluation is done on the basisof – AE during the study period, The efficacy will be assessed by ClinicalGlobal Impression scale done by Investigator.
Thestudy is conducted in India and about 200 subjects will be enrolled in thisstudy.The study duration is approximately 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects in the age group of 18-45 years (with painful menses) 2)Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from the parent and/ or the legally accepted representative.
- •Patients who had at least 6 months previous history of confirmed diagnosis of Primary Dysmenorrhoea, colic.
排除标准
- •Not willing to sign ICF 2)Patients known, or thought to be hypersensitivity, to study drugs 3)Pregnant and lactating women 4)Patients with a history of hypersensitivity to Camylofin or Paracetamol 5)Patients with prostatic hypertrophy 6)Patients with glaucoma 7)Patients with mechanical stenosis 8)Patients with serious underlying organic disorders 9)Patients with paralytic ileus 10)Patients with renal or hepatic disorders 11)Patients with previous history of heart problems or stroke 12)Participation in other clinical trials the last three months and doing study.
结局指标
主要结局
The Primary objective of this Phase IV trial is to find out safety & tolerability of the product
时间窗: Day 5 (after 4 days of therapy)
次要结局
- The secondary objective of this Phase IV trial is to find out efficacy of the product by clinical global impression(Day 5 (after 4 days of therapy))
研究者
研究点 (3)
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