Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01272934
First received: January 7, 2011
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Ankle Sprain |
Drug: Diclofenac Sodium Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Pain on Movement [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
Secondary Outcome Measures:
- Onset of Pain Relief [ Time Frame: On day 1 ] [ Designated as safety issue: No ]Onset of perceptible pain relief.
| Enrollment: | 205 |
| Study Start Date: | January 2011 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Other: Placebo
Topical gel-4 times daily
|
|
Experimental: Diclofenac sodium topical gel 1%
Diclofenac sodium topical gel 1%
|
Drug: Diclofenac Sodium
Topical gel 1%-4 times daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272934
Locations
| Germany | |
| NCH investigative site | |
| Bad Nauheim, Germany | |
| NCH investigative site | |
| Brühl, Germany | |
| NCH investigative site | |
| Cologne, Germany | |
| NCH investigative site | |
| Essen, Germany | |
| NCH investigative site | |
| Gilching, Germany | |
| NCH investigative site, Munich, Germany. | |
| Munich, Germany | |
Sponsors and Collaborators
Novartis
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01272934 History of Changes |
| Other Study ID Numbers: | VOSG-P-318 |
| Study First Received: | January 7, 2011 |
| Results First Received: | August 7, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Ankle Sprain, soft tissue injury |
Additional relevant MeSH terms:
|
Sprains and Strains Ankle Injuries Wounds and Injuries Leg Injuries Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013