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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: December 1, 2010
Last updated: September 3, 2012
Last verified: September 2012
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 Intervention Phase
Ankle Sprain
Drug: Diclofenac sodium topical gel 1%
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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:
  • Pain on Movement [ Time Frame: 24 hours and 7 days ] [ Designated as safety issue: No ]
    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"

  • Onset of Pain Relief [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Onset of perceptible pain relief

  • Tenderness [ Time Frame: Change from baseline at 24 and 72 hours, 7 days ] [ Designated as safety issue: No ]
    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.

  • Ankle Joint Function [ Time Frame: 24 and 72 hours, 7 days ] [ Designated as safety issue: No ]
    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.

Enrollment: 206
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255423

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
Study Director: Study Director Novartis
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01255423     History of Changes
Other Study ID Numbers: 197-P-320 
Study First Received: December 1, 2010
Results First Received: June 8, 2012
Last Updated: September 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Ankle sprain, soft tissue injury

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016