A Clinical Study to Assess the Efficacy and Onset of Pain Relief of Topical MFC51123 Diclofenac-Menthol Gel Versus Controls in Ankle Sprain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 3
- 主要终点
- Area Under the Curve From Day 1 to Day 3 (AUC1-3 Days) of Pain Intensity(PI) on Movement for Diclofenac/Methanol Gel and Placebo Gel
研究概览
简要总结
This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical MFC51123 gel registration.
详细描述
This is a multi-center, randomized, double-blind, repeat-dose, placebo-controlled, parallel-group trial in participants with ankle sprain. Eligible participants will be randomly assigned to one of four treatment groups (1% diclofenac plus 3% menthol gel, 1% diclofenac plus 0.09% menthol gel, 3% menthol gel or placebo gel with 0.09% menthol). Treatment will be self-administered by participants four times daily on an out-patient basis. Participants will rate pain intensity score (NRS) at rest and on movement, pain relief score (PRS) and cooling and soothing sensations. After leaving the clinic, participants will continue to complete scheduled pain intensity and pain relief assessments and answer questions about cooling sensation by answering questions in a paper diary card. The investigator (or designee) will measure the ankle swelling via the 'figure-of-eight' method on treatment Days 1 (at Baseline), 3, 7 and 10.
Participants will continue treatment until they are pain free or for up to 10 days, whichever occurs first. At the end of the treatment, participants will be assessed for function of the injured joint by the investigator. In addition, the participants will evaluate treatment satisfaction, sensory features of the gel and provide a global assessment of the treatment by using a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 16-65 years
- •Good general and mental health
- •Grade I or Grade II acute sprain of the lateral ankle within 24 hours of Visit 1, a pain intensity score of the ankle sprain that is ≥ 5 as measured on an 11-point numerical rating scale, and a peri-malleolar edema (sub-malleolar perimeter difference of ≥ 20mm between injured and uninjured ankle
- •Females of child-bearing age practicing a reliable method of contraception
排除标准
- •Pregnant or breast-feeding females
- •If participant has treated the ankle sprain with treatment such as oral or other topical pain relief medications, massage or physical therapy since experiencing the ankle sprain
- •Acute or chronic pain disorders, which may confound the study pain evaluations
- •Participant has has injury to both ankles or to both medial and lateral ligaments of the same ankle
- •Known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
- •Participant has a medical history of renal or hepatic disease, a current active peptic ulcer or a history of upper gastrointestinal bleeding or perforation related to previous NSAID therapy
研究组 & 干预措施
1% diclofenac sodium plus 3% menthol
1% diclofenac sodium plus 3% menthol gel supplied in 30 gram (g) tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
干预措施: 1% diclofenac sodium plus 3% menthol (Drug)
1% diclofenac sodium plus 0.09% menthol
1% diclofenac sodium plus 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
干预措施: 1% diclofenac sodium plus 0.09% menthol (Drug)
3% menthol
3% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
干预措施: 3% menthol (Drug)
Placebo with 0.09% menthol gel
Placebo with 0.09% menthol gel supplied in 30g tubes sufficient for each subject to apply 4g of gel to the injured ankle region four times daily for up to 10 days.
干预措施: Placebo with 0.09% menthol gel (Drug)
结局指标
主要结局
Area Under the Curve From Day 1 to Day 3 (AUC1-3 Days) of Pain Intensity(PI) on Movement for Diclofenac/Methanol Gel and Placebo Gel
时间窗: up to 72 hours
AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing.
次要结局
- Time of Onset of Meaningful Pain Relief (TOMR)(up to 10 days (end of study))
- Patient's Global Assessment in Response to Treatment (PGART)(up to Day 10)
- PID at Rest(Baseline to 10 days)
- Total Pain Relief (TOTPAR)(Baseline to 168 hours)
- AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo(up to 72 hours)
- Time of Onset of Pain Relief (TOPR)(Baseline to 10 days (end of study))
- Pain Intensity Difference (PID) on Movement(Baseline to 10 days)
- Pain Relief Score (PRS)(Day 1 to Day 7)
- Sum of Pain Intensity Difference (SPID)(Baseline to Day 7)
- Skin Temperature(At 10, 30, 60 minutes, 4 and 6 hours)
- Time of Onset of Cooling Sensation (TOCS)(up to 6 hours)
- Ankle Swelling(Day 1 (baseline), 3, and 7)
- Time to Complete Recovery(up to 240 hours)