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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931866
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : August 16, 2010
Information provided by:
Cerimon Pharmaceuticals

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 mild to moderate soft tissue injuries when applied to the painful area.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in average pain during daily activity at Day 7 [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. Change in average pain during daily activity at Day 14 [ Time Frame: Day 14 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931866

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United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Cerimon Pharmaceuticals
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Responsible Party: Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals Identifier: NCT00931866    
Other Study ID Numbers: DCF-006
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010
Keywords provided by Cerimon Pharmaceuticals:
acute pain
Acute Pain due to Mild to Moderate Soft Tissue Injury
Additional relevant MeSH terms:
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Acute Pain
Soft Tissue Injuries
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action