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Pain | A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:1% diclofenac sodium plus 3% mentholTo be applied four times daily for 10 days.

Drug:1% diclofenac sodium plus 0.09% mentholTo be applied four times daily for 10 days.

Drug:3% mentholTo be applied four times daily for 10 days.

Drug:Placebo with 0.09% menthol gelTo be applied four times daily for 10 days.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1% diclofenac sodium plus 3% menthol1% 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.

1% diclofenac sodium plus 0.09% menthol1% 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.

3% menthol3% 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.

Placebo with 0.09% menthol gelPlacebo 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.

Study Status

Completed

Start Date: November 1, 2013

Completed Date: March 22, 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 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

Secondary Outcome: AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo

Study sponsors, principal investigator, and references

Principal Investigator: GSK Clinical Trials

Lead Sponsor: GlaxoSmithKline

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02100670

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