Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
Phase 4
Completed
- Conditions
- Ankle Sprain
- Interventions
- Drug: placebo
- Registration Number
- NCT01666197
- Lead Sponsor
- Novartis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description diclofenac potassium 25 mg tablet diclofenac potassium 25 mg tablet - placebo placebo -
- Primary Outcome Measures
Name Time Method Pain on Movement 48 hours Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigator
🇩🇪Köln, Germany