Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00931866
First received: June 29, 2009
Last updated: August 12, 2010
Last verified: August 2010
  Purpose

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.


Condition Intervention Phase
Acute Pain
Soft Tissue Injury
Drug: Diclofenac Sodium
Drug: Matching Placebo Patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Soft Tissue Injuries

Resource links provided by NLM:


Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Change in average pain during daily activity at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in average pain during daily activity at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment: 407
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Sodium Patch Drug: Diclofenac Sodium
Topical diclofenac patch applied once daily to area of pain
Placebo Comparator: Topical Placebo Patch Drug: Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931866

Locations
United States, Texas
PPD
Austin, Texas, United States
Sponsors and Collaborators
Cerimon Pharmaceuticals
PPD
  More Information

No publications provided

Responsible Party: Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00931866     History of Changes
Other Study ID Numbers: DCF-006
Study First Received: June 29, 2009
Last Updated: August 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerimon Pharmaceuticals:
diclofenac
acute pain
topical
patch
Acute Pain due to Mild to Moderate Soft Tissue Injury

Additional relevant MeSH terms:
Soft Tissue Injuries
Wounds and Injuries
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014