A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain
A Clinical Study to Assess the Efficacy and Onset of Pain Relief of Topical MFC51123 Diclofenac-Menthol Gel Versus Controls in Ankle Sprain
2 other identifiers
interventional
385
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Nov 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2015
CompletedResults Posted
Study results publicly available
January 12, 2018
CompletedJanuary 12, 2018
May 1, 2017
1.3 years
March 27, 2014
June 2, 2016
January 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
up to 72 hours
Secondary Outcomes (13)
AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo
up to 72 hours
Pain Intensity Difference (PID) on Movement
Baseline to 10 days
PID at Rest
Baseline to 10 days
Pain Relief Score (PRS)
Day 1 to Day 7
Sum of Pain Intensity Difference (SPID)
Baseline to Day 7
- +8 more secondary outcomes
Study Arms (4)
1% diclofenac sodium plus 3% menthol
EXPERIMENTAL1% 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% menthol
EXPERIMENTAL1% 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% menthol
EXPERIMENTAL3% 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 gel
PLACEBO COMPARATORPlacebo 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.
Interventions
To be applied four times daily for 10 days.
To be applied four times daily for 10 days.
To be applied four times daily for 10 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
PAREXEL International - Sites in Germany
Berlin, D-14050, Germany
PAREXEL International, LLC
Berlin, D-14050, Germany
pro scientia med im MARE Klinikum
Kiel, 24119, Germany
Related Publications (1)
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.
PMID: 28345425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 1, 2014
Study Start
November 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 22, 2015
Last Updated
January 12, 2018
Results First Posted
January 12, 2018
Record last verified: 2017-05