- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00931866
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
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 Soft Tissue Injuries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild to moderate soft tissue injuries.
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 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary in which assessments including pain intensity and pain relief will be recorded twice daily. Functional disability and global impression of change will be recorded in the diary at study visits, 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States
- PPD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female subjects 18-75 years of age
- Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle)
- Meet baseline pain criterion
Exclusion Criteria:
- Open wound or infection at site of injury
- Evidence of severe injury, including fracture or nerve injury
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Diclofenac Sodium Patch
|
Topical diclofenac patch applied once daily to area of pain
|
PLACEBO_COMPARATOR: Topical Placebo Patch
|
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in average pain during daily activity at Day 7
Time Frame: Day 7
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in average pain during daily activity at Day 14
Time Frame: Day 14
|
Day 14
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Soft Tissue Injuries
- Acute Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- DCF-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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