Clinical trial NCT02100670: A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain
Official title: A Clinical Study to Assess the Efficacy and Onset of Pain Relief of Topical MFC51123 Diclofenac-Menthol Gel Versus Controls in Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 385
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: up to 72 hours
Secondary outcomes:
measure: AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo
timeFrame: up to 72 hours
measure: Pain Intensity Difference (PID) on Movement
timeFrame: Baseline to 10 days
measure: PID at Rest
timeFrame: Baseline to 10 days
measure: Pain Relief Score (PRS)
timeFrame: Day 1 to Day 7
measure: Sum of Pain Intensity Difference (SPID)
timeFrame: Baseline to Day 7
measure: Time of Onset of Pain Relief (TOPR)
timeFrame: Baseline to 10 days (end of study)
measure: Time of Onset of Meaningful Pain Relief (TOMR)
timeFrame: up to 10 days (end of study)
measure: Time of Onset of Cooling Sensation (TOCS)
timeFrame: up to 6 hours
measure: Total Pain Relief (TOTPAR)
timeFrame: Baseline to 168 hours
measure: Skin Temperature
timeFrame: At 10, 30, 60 minutes, 4 and 6 hours
measure: Ankle Swelling
timeFrame: Day 1 (baseline), 3, and 7
measure: Time to Complete Recovery
timeFrame: up to 240 hours
measure: Patient's Global Assessment in Response to Treatment (PGART)
timeFrame: up to Day 10
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: PAREXEL International - Sites in Germany
city: Berlin
country: Germany
facility: PAREXEL International, LLC
city: Kiel
country: Germany
facility: pro scientia med im MARE Klinikum
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lai PM, Collaku A, Reed K. Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial. J Int Med Res. 2017 Apr;45(2):647-661. doi: 10.1177/0300060517700322. Epub 2017 Mar 27.