Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study
Condition: Pain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This study is a Phase III, randomized, double blind, multi-center, active controlled,
      2-treatment arm, parallel group, non-inferiority study to evaluate the efficacy and safety of
      diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16%
      gel applied four times daily for 7 days in participants with acute ankle sprain. The
      participants who experience an acute Grade I -II ankle sprain within the past 24 hours, and
      pain on movement of at least 50 millimeter (mm) on a 100 mm visual analogue scale (VAS) and
      who will meet all inclusion and exclusion criteria will be randomized in a 1:1 ratio,
      immediately post injury. All participants will receive 4 tubes of study drug, for treatment
      in morning, noon, late afternoon, and late evening, respectively. The very first dose of
      study drug will be applied at the study center. The participants will be instructed to apply
      the gel topically with the finger tips for approximately 1 minute in the morning, at noon,
      late afternoon, and late evening for 7 days. Each tube will be labeled for use at one of
      these 4 times. After the randomization visit (Visit 1/baseline visit- Day 1), participants
      will return to the study site for post baseline visits- Visit 2 (Day 3), Visit 3 (Day 5), and
      Visit 4 (Day 8 +/- 1 d) to complete efficacy and safety assessments. Baseline safety
      laboratory test blood samples will be taken at Visit 1. End of study safety laboratory tests
      will be performed at Visit 4, or in case of early termination on the day of termination. In
      addition, the participants (ex-clinic) will assess pain intensity and pain relief at frequent
      intervals on Day 1 and then at each study drug application throughout the rest of the study.
    

Intervention name(s): Diclofenac diethylamine 2.32% gel; Diclofenac diethylamine 1.16% gel; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will apply DDEA 2.32% gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 two times daily for 7 days.; Participants will apply DDEA 1.16 % gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 four times daily for 7 days.; Participants will apply Placebo gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 two times daily for 7 days.
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ankle sprain; diclofenac diethylamine