CTRI/2024/12/078427已完成Unknown
A Prospective, Single-Arm, Multi-Centric, Open-Label, Post-Market Observational Surveillance (PMOS) Study To Evaluate The Clinico-Epidemiological Profile And Effectiveness Of A Fixed-Dose Combination (FDC) Of Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup For The Symptomatic Management Of Dry Cough In Patients Not Responding To Non-Opioid Based Antitussives
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- To evaluate the clinico-epidemiological profile of patients presenting with dry cough.
研究概览
简要总结
This is a prospective, multicenter, single-arm, open-label, Post-Market Observational Surveillance (PMOS) Study designed to evaluate the effectiveness and safety of FDC of codeine phosphate 10 mg + Triprolidine HCl 1.25 mg per 5ml oral syrup in the management of dry cough. This multicenter study will enroll 250 adult patients with dry cough, not responding to non-opioid-based antitussives. The patients will be followed up for 7 (± 2) days after enrollment into the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both sexes greater than18 years of age.
- •Patients diagnosed with dry cough for at least 1 week and not responding to non-opioid-based antitussives.
- •Patients prescribed codeine phosphate and triprolidine combination for symptomatic relief of dry cough.
- •Dry cough associated with any etiology, as per the discretion of the treating physician and in accordance with the prescribing information.
- •Patients willing and able to comply with the study procedures and sign the informed consent.
排除标准
- •Patients in whom Codeine phosphate and Triprolidine HCL are contraindicated.
- •Patients with a known history of hypersensitivity or idiosyncratic reaction to any ingredients of the product.
- •Patients having respiratory depression, COPD, Asthma attack.
- •Patients having alcohol intoxication, Narrow-angle glaucoma, Urinary retention, raised intracranial tension, Head injury.
- •Patients having peptic ulcer, Paralytic ileus, Intestinal Obstruction, Biliary or gall bladder problem.
- •Patients having severe hypertension, severe coronary artery disease.
- •Patients having severe hepatic or renal diseases, Mono Aminase Oxidase Inhibitor (MAOI) therapy or for 2 weeks after stopping MAOI therapy, known CYP2D6 ultra-rapid metabolizers Pregnant or breast-feeding women, Newborn or premature infants.
结局指标
主要结局
To evaluate the clinico-epidemiological profile of patients presenting with dry cough.
时间窗: Day 1 and 7
次要结局
- Effectiveness(1. To evaluate the effectiveness of codeine)
研究者
Dr Deepak Talwar
Metro Multispeciality Hospital
研究点 (7)
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