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Completed

NCT Number: NCT01255423

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

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.

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Key information

Conditions

Ankle Sprain Ankle Injuries Leg Injuries Soft Tissue Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Diclofenac sodium topical gel 1%

Drug

Diclofenac sodium topical gel 1%, 4 times daily

Placebo

Drug

Placebo, 4 times daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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