CTRI/2026/03/106699招募中Unknown
Post Marketing Study of Aceclofenac + Drotaverine Tablets in the Treatment of Acute Abdominal Colicky Pain (Biliary Colic, Ureteric Colic)
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
- 9
- 主要终点
- To assess the safety, tolerability, and effectiveness of Aceclofenac (100 mg) + 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 acute abdominal colic pain.
Patients will receive one tablet twice daily for 5 days. The objective of the study is to document real life safety, tolerability and efficacy of study medication.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients aged 18 to 65 years (both inclusive) 2.Patients with presence and history of biliary or ureteric colic as confirmed by ultrasound 3.Patients with mild to moderate pain requiring oral therapy 4.Patients with history of at least one episode of colicky pain within 24 hours prior to screening and not requiring hospitalization.
排除标准
- •1.Patients with presence of severe or chronic abdominal colic pain requiring parenteral treatment 2.Patients with colic pain other than biliary or ureteric colic 3.Patients with hypersensitivity to Aceclofenac, Drotaverine or to any of the excipients 4.Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticria) in response to ibuprofen, aspirin or other NSAIDs 5.Patients with active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) 6.Patients with history of gastrointestinal bleeding or perforation related to previous NSAID therapy 7.Patients with severe heart failure, hepatic failure and renal failure 8.Patients with presence/history of porphyria 9.Patients with history of active bleedings or bleeding disorders 10.Patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and or cerebrovascular disease 11.Patients with second or third degree atrioventricular block, cardiogenic shock and arterial hypotension 12.Pregnant or lactating women 13.Patients who are on any other prescription analgesics or antispasmodic medications within the previous week before study enrollment 14.Patients with presence history of cognitive impairment, alcohol abuse, psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments 15.Patients with any other clinically significant illness or conditions which may interfere in the inclusion of a patient in the study as per the investigator’s opinion.
结局指标
主要结局
To assess the safety, tolerability, and effectiveness of Aceclofenac (100 mg) + Drotaverine (80 mg) tablets
时间窗: Baseline, Follow Up Visit Day 3 End of the Study Visit Day 5
次要结局
- Mean change in pain intensity score(0, 2, 4, 8, 24, 48, 72, 96, 120 hours)
- Mean change in pain relief score(2, 4, 8, 24, 48, 72, 96, 120 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 (9)
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