Phase 4
Completed N=100
Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
Ankle Sprain
Source: ClinicalTrials.gov NCT01666197 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Pain on Movement — 31.3; 59.2 mm
Summary
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on Movement |
31.3; 59.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18 years and over.
- Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
- Injury within past 12 hours.
Exclusion Criteria
- Pain medication was taken within the 6 hours that precede randomization.
- During the past 3 months: Grade I-III sprain of the same ankle.
- During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
- Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
- Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Data sourced from ClinicalTrials.gov (NCT01666197). 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. Informational only — not medical advice.