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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00869180

Acronym

SUPPORT 2

Enrollment

219

Registered

2009-03-25

Start date

2009-02-28

Completion date

2009-08-31

Last updated

2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Ankle Sprain

Keywords

diclofenac, ankle sprain, acute pain, topical, patch, Acute Pain due to Mild to Moderate Ankle Sprain

Brief 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.

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.

Interventions

DRUGDiclofenac Sodium

Topical diclofenac patch applied once daily to area of pain

DRUGMatching Placebo Patch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in average pain during daily activity at Day 3	Day 3

Secondary

Measure	Time frame
Change in average pain during daily activity at Day 7	Day 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026