Phase 3
N=302
Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study
Pain
Bottom Line
View on ClinicalTrials.gov: NCT04052620 ↗Enrolled (actual)
302
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Change From Baseline in Pain on Movement (POM) on Day 5 of Treatment as Assessed by a 100 Millimeter (mm) Visual Analogue Scale (VAS) — -42.36; -43.47 mm — p=0.5950
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diclofenac diethylamine 2.32% gel (Drug); Diclofenac diethylamine 1.16% gel (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain on Movement (POM) on Day 5 of Treatment as Assessed by a 100 Millimeter (mm) Visual Analogue Scale (VAS) |
-42.36; -43.47 | 0.5950 |
| SECONDARY Number of Participants With Severity of Adverse Events (AEs) Following Dosing With Study Medication |
9; 8; 2; 4; 0; 0 | — |
| SECONDARY Change From Baseline of POM on VAS on Day 3 and Day 8 of Treatment Assessed by 100 mm VAS |
-28.29; -25.86; -55.38; -54.62 | 0.2536 |
| SECONDARY Change From Baseline in Tenderness as Measured by Pressure Algometry on Days 3, 5 and 8 |
6.92; 5.72; 9.84; 10.76; 17.06; 15.60 | 0.3118 |
| SECONDARY Changes From Baseline in Difference of Tenderness Between Affected Ankle and Contralateral Ankle Measured by Algometry on Days 3, 5 and 8 |
7.85; 7.59; 11.34; 12.59; 16.64; 14.98 | 0.8360 |
| SECONDARY Change From Baseline in Ankle Joint Function (Karlsson Scoring Scale) on Days 3, 5 and 8 |
16.26; 15.52; 27.94; 28.22; 41.87; 39.75 | 0.6242 |
| SECONDARY Change From Baseline in Circumference of Affected Ankle (Swelling) as Measured by Figure of Eight Method on Days 3, 5 and 8 |
-0.42; -0.24; -0.97; -0.57; -1.25; -0.87 | 0.1554 |
| SECONDARY Change From Baseline in Difference of Circumference (Swelling) Between Affected Ankle and Contralateral Ankle by Figure of Eight Method on Days 3, 5 and 8 |
-0.41; -0.29; -0.83; -0.66; -1.12; -0.92 | 0.2182 |
| SECONDARY Sum of Pain Intensity Difference (SPID) From 0 to 24 Hours Post First Dose (Day 1) and From 96 to 120 Hours Post First Dose (Day 5) |
15.80; 15.43; 9.80; 10.29 | 0.6545 |
| SECONDARY Total Pain Relief (TOTPAR) From 0 to 24 Hours Post First Dose (Day 1) and From 96 to 120 Hours Post First Dose (Day 5) |
8.47; 8.53; 28.48; 27.68 | 0.9491 |
| SECONDARY Mean Number of Rescue Medication Tablets Used to Treat Ankle Pain |
2.4; 2.6 | — |
| SECONDARY Number of Days on Which Rescue Medication Was Used to Treat Ankle Pain |
— | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of diclofenac diethylamine 2.32 percent (%) gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily for 7 days in participants with acute ankle sprain.
Eligibility Criteria
Inclusion Criteria
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment will be performed.
- A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
- A participant with acute sprain of the lateral ankle on one side only, Grade I-II.
- A participant who had pain-on-movement greater than or equal to (>=) 50 mm on a 100 mm VAS.
- A participant with injury within the past 24 hours before randomization.
- Participant had not taken pain medication within the 24 hours that precedes randomization.Treatment by rest, ice, compression, or elevation (RICE) is authorized prior to randomization. Stable daily doses of acetylsalicylic acid (less than or equal to [ =1.5 times the upper limit of normal [ULN]), hepatic disease (ALT or AST >= 2 times the ULN), or subject with allergic disease at screening that may increase the risk associated with study participation.
- A participant with history of regular alcohol consumption exceeding 14 drinks per week (1 drink = 5 ounces [150 milliliter {mL}] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of Screening.
- A participant who has received treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer).
- A participant who has previously been enrolled in this study.
- A participant with any physical impairment that would influence the study's efficacy evaluations, in particular POM and the ankle joint function, such as : peripheral or central neurological disease, significant back pain, symptomatic osteoarthritis of the hips, knees or feet, or any painful conditions of the lower extremities (e.g. painful nail, wound, corn, or wart).
Data sourced from ClinicalTrials.gov (NCT04052620). 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.