Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Information source: Cerimon Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain; Ankle Sprain
Intervention: Diclofenac Sodium (Drug); Matching Placebo Patch (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Cerimon Pharmaceuticals
Summary
The primary purpose of this study is to assess the effectiveness of once daily application
of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle
sprains when applied to the painful area.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in average pain during daily activity at Day 3
Secondary outcome: Change in average pain during daily activity at Day 7
Detailed description:
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in
patients with mild or moderate ankle sprains.
Eligible patients will be randomized (in a 1: 1 ratio) to receive double-blind treatment with
either the diclofenac topical patch or a matching placebo patch to be applied once daily for
7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up
assessment will be conducted on Day 14. Patients will complete an electronic diary in which
assessments including pain intensity, pain relief and functional disability will be recorded
twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and
the use of study treatment and rescue medication will be recorded in the diary each day.
Eligibility
Minimum age: 17 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female subjects 17 - 75 years of age
- Sustained recent, painful unilateral mild to moderate ankle sprain
- Meet baseline pain criterion
Exclusion Criteria:
- Open wound or infection at site of injury
- Evidence of severe injury or ankle fracture
- Use of oral NSAIDs or opioids within 12 - 24 hours of injury
- Presence or history of peptic ulcers or GI bleeding
- A history of intolerance to NSAIDs, acetaminophen, adhesives
- Positive pregnancy test
- Positive drug screen
Locations and Contacts
PPD, Austin, Texas 78704, United States
Additional Information
Starting date: February 2009
Last updated: January 26, 2010
|