Last updated: 11/07/2018 12:29:16
A multicenter efficacy study of a diclofenac+menthol gel in subjects with ankle sprain
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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:
AUC1-3 days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo
Timeframe: up to 72 hours
Pain Intensity Difference (PID) on movement
Timeframe: Baseline to 10 days
PID at Rest
Timeframe: Baseline to 10 days
Pain Relief Score (PRS)
Timeframe: Day 1 to Day 7
Sum of Pain Intensity Difference (SPID)
Timeframe: Baseline to Day 7
Time of Onset of Pain Relief (TOPR)
Timeframe: Baseline to 10 days (end of study)
Time of Onset of Meaningful Pain Relief (TOMR)
Timeframe: up to 10 days (end of study)
Time of Onset of Cooling Sensation (TOCS)
Timeframe: up to 6 hours
Total Pain Relief (TOTPAR)
Timeframe: Baseline to 168 hours
Skin Temperature
Timeframe: At 10, 30, 60 minutes, 4 and 6 hours
Ankle Swelling
Timeframe: Day 1 (baseline), 3, and 7
Time to Complete Recovery
Timeframe: up to 240 hours
Patient's Global Assessment in Response to Treatment (PGART)
Timeframe: up to Day 10
Interventions:
Drug: 1% diclofenac sodium plus 3% menthol
Drug: 1% diclofenac sodium plus 0.09% menthol
Drug: 3% menthol
Drug: Placebo with 0.09% menthol gel
Enrollment:
385
Observational study model:
Not applicable
Primary completion date:
2015-22-03
Time perspective:
Not applicable
Clinical publications:
http://journals.sagepub.com/eprint/qq4w4FET6ZJbAuEmx6Uq/full.
Medical condition
Pain
Product
diclofenac, diclofenac/levomenthol, levomenthol
Collaborators
Not applicable
Study date(s)
November 2013 to March 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
16 - 65 years
Accepts healthy volunteers
No
- Age: 16-65 years
- Good general and mental health
- 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
Inclusion and exclusion 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
Trial location(s)
Location
PAREXEL International - Sites in Germany
Berlin, Not Available, Germany, D-14050
Status
Study Complete
Location
PAREXEL International, LLC
Berlin, Not Available, Germany, D-14050
Status
Study Complete
Location
pro scientia med im MARE Klinikum
Kiel, Not Available, Germany, 24119
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-22-03
Actual study completion date
2015-22-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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