Phase 3
N=385
A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02100670 ↗Enrolled (actual)
385
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: 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 — 276.97; 282.88 NRS Score (0 - 10 scale) * hrs — p=0.4144
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 1% diclofenac sodium plus 3% menthol (Drug); 1% diclofenac sodium plus 0.09% menthol (Drug); 3% menthol (Drug); Placebo with 0.09% menthol gel (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
276.97; 282.88 | 0.4144 |
| SECONDARY AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo |
276.97; 261.11; 272.65; 282.88 | 0.8761 |
| SECONDARY Pain Intensity Difference (PID) on Movement |
7.8; 7.4; 7.8; 7.7; 0.23; 0.19 | — |
| SECONDARY PID at Rest |
7.8; 7.4; 7.8; 7.7; 0.34; 0.43 | — |
| SECONDARY Pain Relief Score (PRS) |
0.33; 0.29; 0.32; 0.36; 0.44; 0.36 | — |
| SECONDARY Sum of Pain Intensity Difference (SPID) |
4.16; 3.19; 4.72; 4.37; 9.19; 9.13 | — |
| SECONDARY Time of Onset of Pain Relief (TOPR) |
1.03; 4.00; 1.00; 4.00 | 0.5404 |
| SECONDARY Time of Onset of Meaningful Pain Relief (TOMR) |
92.50; 76.83; 72.00; 93.50 | 0.6918 |
| SECONDARY Time of Onset of Cooling Sensation (TOCS) |
0.17; 0.17; 0.17; 0.17 | 0.7003 |
| SECONDARY Total Pain Relief (TOTPAR) |
2.81; 2.64; 3.27; 2.75; 6.86; 6.81 | — |
| SECONDARY Skin Temperature |
27.69; 29.31; 29.92; 30.93; 28.26; 29.81 | — |
| SECONDARY Ankle Swelling |
573.9; 573.6; 577.1; 576.1; 566.2; 566.9 | — |
| SECONDARY Time to Complete Recovery |
240.00; 240.00; 240.00; 240.00 | 0.0408 sig |
| SECONDARY Patient's Global Assessment in Response to Treatment (PGART) |
3; 13; 6; 9; 24; 20 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02100670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.