A Multicenter, Open-label, Single-arm Post Marketing Surveillance study of the Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- To assess the safety profile of Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm.
研究概览
简要总结
This Multicenter, Open-label, Single-arm Post-Marketing Surveillance (PMS) study evaluates the Fixed-Dose Combination (FDC) of Drotaverine 80 mg and Aceclofenac 100 mg in patients with colicky pain due to smooth muscle spasm. Patients will receive one tablet once daily for 2-3 days, with assessments conducted at screening, enrollment, and end-of-study visits. The primary objective is to assess the safety profile, while the secondary objective is to evaluate the efficacy of the combination therapy. Key endpoints include adverse event incidence, quality of life changes, pain severity reduction, and Physician’s Global Assessment of treatment response.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects meeting following criteria will be included in the study:
- •All patients with duly filled in ICFs [Informed Consent Forms]
- •18-45 years of age.
- •Diagnosis of the Colicky pain due to smooth muscle spasm/ visceral colic like primary dysmenorrhea, biliary colic and ureteric colic.
排除标准
- •Subjects will be excluded from the study for any of the following reasons:
- •Patients unwilling to sign on ICF
- •Participation in other trials,
- •Concomitant therapy,
- •Pregnancy or breast feeding,
- •Inadequate contraception,
- •Dementia,
- •Alcohol or drug dependence,
- •Concomitant serious medical condition.
- •Hypersensitivity to Drotaverine or Aceclofenac,
- •Pituitary disease, and
- •Concomitant use of sex hormones except oral contraceptives for which the doses will be unchanged.
- •Any other serious diseases having fatal progression.
- •Any of the following endocrinological diseases: diabetes mellitus, hypo- /hyperthyreosis, pituitary tumor.
- •Clearly kidney or liver disease, abnormal kidney or liver function.
结局指标
主要结局
To assess the safety profile of Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm.
时间窗: Baseline, Visit 2 & Visit 3
次要结局
- To assess the efficacy profile of Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm.(Baseline, Visit 2 & Visit 3)