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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2011

Interventions

  • Drug: Diclofenac Sodium
    • Topical gel 1%-4 times daily
  • Other: Placebo
    • Topical gel-4 times daily

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Diclofenac sodium topical gel 1%
    • Diclofenac sodium topical gel 1%

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Onset of Pain Relief
    • Time Frame: On day 1
    • Onset of perceptible pain relief.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor

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