A prospective, open-label, multicentre, active controlled, comparative, post marketing study to evaluate the safety and efficacy of FDC of nimesulide-paracetamol as compared to FDC of aceclofenac-paracetamol and ketorolac in patients with acute painful conditions
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Reduction of pain as measured by numerical rating scale as compared to baseline in the three groups
研究概览
简要总结
Various NSAIDS and their combinations with paracetamol have been approved in India and are being used for management of patients with various painful conditions. All these NSAIDs have some differences in the pharmacodynamics and pharmacokinetic properties having an overall impact on the efficacy and safety of the products. The current post marketing study is being undertaken to evaluate and compare the safety and efficacy of the three commonly used combination of NSAIDS i.e. Nimesulide (100mg) + Paracetamol (325mg) tablets, Aceclofenac (100mg) + Paracetamol (325mg) tablets and Ketorolac (10mg) in patients with acute painful conditions like low back pain, acute musculoskeletal disorders and trauma such as tendinitis, tenosynovitis, bursitis, sprains and strains, migraine, dental pain, painful dental procedures and post-surgical pain. The patients enrolled in the study will be randomly given either of the three study drugs for management of their painful conditions as per investigators discretion as per routine clinical practice for the duration not exceeding 10 days for Nimesulide (100mg) + Paracetamol (325mg) tablets and Aceclofenac (100mg) + Paracetamol (325mg) tablets & 7 days for Ketorolac (10mg). The patients will be followed upto 14 days after study initiation. The patients will be followed up on weekly intervals and will undergo clinical examination and laboratory investigations to evaluate the efficacy, safety and tolerability of the three medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender ≥ 18 years of age 2.Patients with acute painful conditions like low back pain, acute musculoskeletal disorders and trauma such as tendinitis, tenosynovitis, bursitis, sprains and strains, migraine, dental pain, painful dental procedures and post-surgical pain receiving either FDC of nimesulide-paracetamol or FDC of aceclofenac-paracetamol or ketorolac as per routine clinical practice 3.Patients willing to provide written informed consent.
排除标准
- •1.Patients with past history of hypersensitivity to study drugs 2.Patients who have used NSAIDS or any other analgesic in last 24 hours 3.Patients with history of GI bleeding 4.Patients with clinically significant uncontrolled cardiovascular disease 5.Patients with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening 6.Pregnant and lactating mothers and women of child bearing potential who are not taking adequate contraceptive measures 7.Patients prescribed / require any other medication known to interact with the study medication.
- •8.Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Reduction of pain as measured by numerical rating scale as compared to baseline in the three groups
时间窗: 7 days and 14 days
次要结局
- Change in liver function tests/parameters from baseline to Week 2. [LFT will be assessed by AST, ALT, Serum Bilirubin] in the three groups(14 days)
- Change in renal function tests/parameters from baseline to Week 2. [KFT will be assessed by serum creatinine and blood urea nitrogen] in the three groups(14 days)
- Gastrointestinal adverse events reported (any epigastric pain, upper GI bleeding, peptic ulcer, etc.) during the two weeks follow-up in the three groups(7 days and 14 days)
- Cardiovascular adverse events (any MI, any stroke or any CV death) during the two weeks follow-up in the three groups(7 days and 14 days)
- Other Adverse events reported during the two weeks follow-up in the three groups(14 days)