CTRI/2011/091/000150已完成3 期
A Randomized, open labeled, comparative , parallel group, multicentric trial to evaluate the efficacy and safety of the proposed fixed dose combination of Tramadol 50 mg IR + Diclofenac 75 mg SR vs standard / approved fixed dose combination of Tramadol 37.5 mg + Paracetamol 325 mg in treatment of patients with moderate to severe pain due to acute musculoskeletal conditions , acute flare of osteoarthritis , acute flare of rheumatoid arthritis and post operative pain
Abbott Healthcare Private Limited, Mumbai3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年12月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- 1. Reduction in pain intensity from baseline to all visits.2. Pain relief at the end of the study
研究概览
简要总结
A Randomized, open labeled, comparative , parallel group, multicentric trial to evaluate the efficacy and safety of the proposed fixed dose combination of Tramadol 50 mg IR + Diclofenac 75 mg SR vs standard / approved fixed dose combination of Tramadol 37.5 mg + Paracetamol 325 mg in treatment of patients with moderate to severe pain due to acute musculoskeletal conditions , acute flare of osteoarthritis , acute flare of rheumatoid arthritis and post operative pain.The study will be conducted at 3 centres in India only. 200 patients satisfying the Inclusion / Exclusion criteria will be enrolled in the trail and will recieve either of the two treatments as per randomization chart and will be followed up for 5 days to analyse the pain relief and reduction in pain intensity at end of 5 days treatment.Patient FPFV (First Patient First Visit) was 12th Oct 2010.
研究设计
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
入选标准
- •1.Males and females aged above 18 years and less than 70 years (women of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, contraceptive pill or depot gestagen) throughout the study).
- •2.Clinical diagnosis of acute musculoskeletal pain (tendinitis, Bursitis, synovitis) acute flare of osteoarthritis, acute flare of Rheumatoid arthritis and post operative pain3.Subjects with moderate pain confirmed by a VAS Score > 50 mm in the scale during the last 5 days prior to the Baseline Visit.
- •(In post operative pain only those subjects will be screened who can take oral medications)4.Subjects must be willing to discontinue all other analgesics / existing analgesic treatment.
- •5.Subjects willing to give informed consent.6.Subjects willing to fill patient diary cards/ patient assessment forms and comply with the study procedure and requirements.
排除标准
- •1.Pregnant and nursing women2.Patients hypersensitive to Tramadol, Diclofenac and paracetamol .3.Subjects previously discontinued from tramadol, diclofenac and paracetamol therapy due to adverse effects 4.Subjects had undergone therapy with Tramadol within 30 days before study entry.5.Subjects had received antidepressants therapy within 4 weeks of study entry.6.Subjects diagnosed with fibromyalgia, active peptic ulcer , GI tract bleeding.7.Subjects also with the history of peptic ulcers, gastric irritations and NSAIDs intolerance 8.Subjects with abnormal renal and liver function parameters9.Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine for the pain.
- •10.Ancillary physiotherapy massage or physical therapy within 48 hours.11.Subjects had acupuncture within 3 weeks of study entry.12.Subjects treated with intra- articular injection of corticosteroids within two months.13.History of chronic condition(s) (expect OA & RA) , requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout) and severe respiratory disease.
- •14.Subjects with history of abnormal / impaired creatinine clearance .15.Substance or alcohol abuse, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behavior.
- •16.Untreated depression or other psychiatric disorder in such a way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
- •17.Subject with a history of attempted suicide or substance abuse.18.Subjects, who are unsuitable for any other reason to participate in the study in the opinion of the Investigator.
结局指标
主要结局
1. Reduction in pain intensity from baseline to all visits.2. Pain relief at the end of the study
时间窗: Baseline, Day 3 and Day 5
次要结局
- 1. Disability score measurement from baseline to all visits2. Reduction in swelling and inflammation from baseline to all the visits3. Use of rescue medication 4. Safety parameters5. Global assessment for efficacy and tolerability(Baseline, Day 3 and Day 5)
研究者
研究点 (3)
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