Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

• ClinicalTrials.gov Identifier: NCT01255423
• Recruitment Status: Completed
• First Posted: December 7, 2010
• Results First Posted: October 4, 2012
• Last Update Posted: October 4, 2012
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

Brief Summary:

The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (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 or disease	Intervention/treatment	Phase
Ankle Sprain	Drug: Diclofenac sodium topical gel 1%; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• 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 4 Times Daily in Subjects With Acute Ankle Sprain
• Study Start Date: November 2010
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Diclofenac sodium topical gel 1%	Drug: Diclofenac sodium topical gel 1%; Diclofenac sodium topical gel 1%, 4 times daily
Placebo Comparator: Placebo	Drug: Placebo; Placebo, 4 times daily

Outcome Measures

Primary Outcome Measures :

1. Pain on Movement [ Time Frame: 72 hours ]
   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 :

1. Pain on Movement [ Time Frame: 24 hours and 7 days ]
   Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"
2. Onset of Pain Relief [ Time Frame: Day 1 ]
   Onset of perceptible pain relief
3. Tenderness [ Time Frame: Change from baseline at 24 and 72 hours, 7 days ]
   Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.
4. Ankle Joint Function [ Time Frame: 24 and 72 hours, 7 days ]
   Ankle joint function score (Karlsson Scoring scale which ranges from 0 "worst possible score" to 90 "best possible score")at 24 and 72 hours and 7 days.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria:

1. Male or female aged 18 years and over.
2. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
3. Injury within past 12 hours.

Exclusion criteria:

1. Pain medication was taken within the 6 hours that precede randomization.
2. During the past 3 months: Grade I-III sprain of the same ankle.
3. 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.
4. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
5. 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).

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States

United States, Florida

Aventura, Florida, United States

Hialeah, Florida, United States

Miami, Florida, United States

United States, New Jersey

Berlin, New Jersey, United States

United States, South Carolina

Columbia, South Carolina, United States

United States, Texas

El Paso, Texas, United States

Houston, Texas, United States

United States, Utah

Salt Lake City, Utah, United States

Sponsors and Collaborators

Novartis

Investigators

• Study Director: Study Director; Novartis

More Information

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT01255423
• Other Study ID Numbers: 197-P-320
• First Posted: December 7, 2010
• Results First Posted: October 4, 2012
• Last Update Posted: October 4, 2012
• Last Verified: September 2012

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; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action