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Completed

NCT Number: NCT00869180

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain

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.

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Key information

Conditions

Acute Pain Ankle Injuries Ankle Sprain Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

17 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

PPD

Austin, Texas, 78704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Diclofenac Sodium

Drug

Topical diclofenac patch applied once daily to area of pain

Matching Placebo Patch

Drug

Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

Primary outcomes

  1. Change in average pain during daily activity at Day 3

    Time frame: Day 3

Secondary outcomes

  1. Change in average pain during daily activity at Day 7

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

Cerimon Pharmaceuticals

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study 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

Acronym: SUPPORT 2

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2009
Registry last updated
Jan 28, 2010

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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