Clinical study to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 7
- 主要终点
- The responder rate, defined as the percent of patients showing at least 50% improvement on VAS.
研究概览
简要总结
This is a comparative, randomized, multicentric, clinical trial to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain. This study is presently being conducted in 100 patients from various centers in India. Patients will be randomized to receive either Fixed Dose Combination of Dexketoprofen trometamol (25 mg) and Paracetamol (500 mg) or Fixed Dose Combination of Diclofenac sodium (50 mg) and Paracetamol (500 mg). Dose will be one tablet to be taken orally, thrice daily for three consecutive days. Major outcomes measured will be Responder rate, reduction in pain intensity on VAS, Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS), Sum of pain intensity differences (SPID) on categorical verbal scale (VS), Total pain relief score (TOTPAR) on VS, patients and physician’s global assessment and ADR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
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 between 18-65 years of age.
- •2.Patients having acute musculoskeletal pain e.g. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain 3.Patients willing to give written informed consent and willing to comply with trial protocol.
- •comply with trial protocol.
排除标准
- •1.Patients previously sensitive to dexketoprofen, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product2.Patients in whom substances with a similar action (e.g. Aspirin, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.3.Patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer or chronic dyspepsia.4.Patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders.5.Patients with Crohn?s disease or ulcerative colitis.6.Patients with a history/ presence of bronchial asthma.7.Patients with severe heart failure8.Patients with moderate to severe renal dysfunction9.Patients with severely impaired hepatic function10.Patients with hemorrhagic diathesis and other coagulation disorders11.Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception12.Treatment with other analgesic and/or anti-inflammatory agent13.Patients who will receive some other drug during the study besides that in the protocol that could alter the bioavailability of the study drug 14.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
结局指标
主要结局
The responder rate, defined as the percent of patients showing at least 50% improvement on VAS.
时间窗: 0,1,6,12,24,48 and 72 hours
次要结局
- Physician?s global assessment of the efficacy of the drug(0,1,6,12,24,48 and 72 hours)
- Total pain relief score (TOTPAR) on VS.(0,1,6,12,24,48 and 72 hours)
- Patient?s global assessment of the efficacy of the drug(0,1,6,12,24,48 and 72 hours)
- Sum of pain intensity differences (SPID) on categorical verbal scale (VS).(0,1,6,12,24,48 and 72 hours)
- Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS)(0,1,6,12,24,48 and 72 hours)