At a glance
ClinicalIndex Comparison Record- ✓Acute lateral ankle sprain, Grade I-II, one side only
- ✓Injury occurred within 24 hours before randomization
- ✓Pain-on-movement ≥50 mm on 100 mm visual analog scale (VAS)
- ✓No pain medication taken within 24 hours before randomization
- ✕Grade I-III ankle sprain or Grade II-III sprain on affected ankle within past 3-6 months
- ✕Pain or instability in affected ankle attributable to previous ankle sprain or trauma
- ✕Ankle sprain attributable to known disease affecting ligaments (e.g., connective tissue disorders)
- ✕Skin lesion or wound in treatment area
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 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 Versus 1.16% Gel in Subjects With Acute Ankle Sprain
In Brief
A Phase 3 clinical trial evaluating Diclofenac diethylamine 2.32% gel, Diclofenac diethylamine 1.16% gel, and 1 other intervention for Pain. Completed, enrolled 313 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.