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, Mumbai0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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 pain
- •3.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 women
- •2.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 parameters
- •9.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.
研究者
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