A clinical trial to assess the efficacy and safety of topical Dexketoprofen Trometamol Gel in the treatment of knee osteoarthritis
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 13
- 主要终点
- Primary efficacy variable is responder rate. The patients with at least 20 % improvement in pain intensity difference (PID) or WOMAC total score (0-4 Likert scale) will be termed as responders.
研究概览
简要总结
This is a multicentric, randomized, comparative clinical trial being conducted to evaluate efficacy and safety of topical Dexketoprofen trometamol gel in treatment of knee osteoarthritis. Reference product will be Diclofenac gel. Total 200 patients (100 in each group) will be enrolled in this study. Study population comprise of subjects with age between 40 - 65 years; diagnosed to have knee osteoarthritis; willing to give written informed consent and willing to comply with trial protocol; and not on any anti-inflammatory or other therapy known to affect the study outcome. Patients will apply the medication locally thrice daily for 2 weeks. Rescue medication: Paracetamol 650 mg tablet every 6 hours, if required. Primary efficacy variable is responder rate. The patients with at least 20 % improvement in pain intensity difference (PID) or WOMAC total score (0-4 Likert scale) will be termed as responders. Secondary efficacy measures are improvement in average VAS scores; improvement in WOMAC scores for pain, stiffness and physical function; and improvement in patient's and physician's global assessment of arthritis. Adverse events (if any) will be recorded. Patients will be evaluated at baseline and after 14 days therapy.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •Male or female patients between 40- 65 years of age.2) Patients diagnosed to have knee osteoarthritis.3) Willing to give written informed consent and willing to comply with the trial protocol.
- •Patients not on any anti-inflammatory or other therapy known to affect the study outcome.
排除标准
- •Patients with known hypersensitivity to the study medications and/or history of any drug allergy or intolerance to NSAIDs.2) Patients with the history of or evidence of any cardiac, renal, hepatic, neurologic or any other major medical or psychiatric illness.
- •Any contraindication to use of NSAID.4) Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception.5) Any condition that, in the opinion of the investigator, does not justify the patients's inclusion in the study.6) Drug addiction or alcoholism7) Current participation or participation within the previous three months in other clinical trials.
结局指标
主要结局
Primary efficacy variable is responder rate. The patients with at least 20 % improvement in pain intensity difference (PID) or WOMAC total score (0-4 Likert scale) will be termed as responders.
时间窗: 0, 14 days
次要结局
- Improvement in average VAS score. Improvement in WOMAC scores for pain, stiffness and physical function. Improvement in patient's and physician's global assessment of arthritis.(0, 14 days)