CTRI/2026/03/106698招募中Unknown
Post Marketing Study of Aceclofenac plus Drotaverine Tablets in the Treatment of Primary Dysmenorrhoea
适应症
相关药物
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- To document the real life safety and tolerability of Aceclofenac (100 mg) plus Drotaverine (80 mg) tablets
研究概览
简要总结
This open label, prospective, active post marketing surveillance study evaluates the Fixed-Dose Combination (FDC) of Drotaverine 80 mg and Aceclofenac 100 mg in patients with primary dysmenorrhoea.
Patients will receive one tablet twice daily for a maximum of 3 days. The objective of study is to document the real-life safety and effectiveness of Aceclofenac (100 mg) + Drotaverine (80 mg) tablets in the management of primary dysmenorrhoea.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients aged between 18 to 35 years (both inclusive) 2.Patients with normal gynecological examination and normal ultrasound findings of uterus and adnexa 3.Female patients with history of primary dysmenorrhoea characterized by painful spasmodic cramping in the lower abdomen, just before and / or during menstruation (lasting for 8 to 72hrs) 4.Patients should have history of onset of primary dysmenorrhic symptoms within 5 years of menarche 5.Patient should have painful menses in at least 4 of previous 6 menstrual cycles 6.Patients reporting a pain intensity of more than or equals to 6 on a 11 point Pain Intensity Numerical Rating Scale (PINRS) 7.Patients should have history of regular menstrual cycles 8.Patients agree to participate and follow up in the study.
排除标准
- •1.Patients with history or presence of recurrent pelvic or lower abdominal pain outside the menstrual period or have dysmenorrhoea secondary to endometriosis, adenomyosis, uterine myomas, endometrial polyps, cervical stenosis or pelvic inflammatory disease 2.Patients with disease or history of abnormalities of the reproductive organs confirmed by clinical examination and ultrasound.
- •3.Patients with presence or history of using intrauterine devices or oral/injectable contraceptives within 6 months 4.Patients receiving NSAIDs for any other condition or with history of intake within 48 hours prior to study 5.Patients with history of peptic ulcer disease, severe gastritis, gastrointestinal bleeding or any other significant comorbidity which may interfere in the study as per the Investigator’s opinion 6.Patients with history of hypersensitivity to drotaverine or NSAIDs 7.Pregnant and lactating women.
结局指标
主要结局
To document the real life safety and tolerability of Aceclofenac (100 mg) plus Drotaverine (80 mg) tablets
时间窗: Baseline to End of Study
次要结局
- Mean change in pain intensity score(0, 2, 4, 8, 24, 48, 72 hours)
- Mean change in pain relief score(2, 4, 8, 24, 48, 72 hours)
- Patients and Physician global impression on study drug effectiveness(End of Study)
- Proportion of Patients requiring rescue medication(End of Study)
研究者
Dr Anil Pareek
Ipca Laboratories Limited
研究点 (15)
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