Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

This study has been terminated.
(Sponsor decision)
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00640705
First received: March 18, 2008
Last updated: September 3, 2008
Last verified: September 2008
  Purpose

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle.

The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.


Condition Intervention Phase
Ankle Sprain
Drug: diclofenac sodium
Drug: Matching placebo patch
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 Pain Due to Mild to Moderate Ankle Sprain.

Resource links provided by NLM:


Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: January 2008
Estimated Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Topical diclofenac sodium patch
Drug: diclofenac sodium
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
Other Name: diclofenac
Placebo Comparator: B
Topical patch identical in appearance to active comparator, except without diclofenac sodium
Drug: Matching placebo patch
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
Other Name: placebo comparator

Detailed Description:

Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.

  Eligibility

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

Inclusion Criteria:

  • 18 to 75 years of age
  • Has sustained a painful Grade 1 or 2 ankle sprain (Appendix H) no more than 48 hours prior to study entry
  • Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)

Exclusion Criteria:

  • Grade 3 ankle sprain or bilateral sprain (see Appendix H)
  • Previous injury to the same ankle within 3 months prior to current injury
  • Aspirin or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (Appendix B)
  • Opioid use within 24 hours prior to study entry
  • Topical treatment, other than ice packs, applied to the painful region since time of injury
  • A history of peptic ulcer disease within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder
  • A history of, or evidence for, underlying disease in the injured ankle, such as osteoarthritis or gout
  • Clinically significant, poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
  • A history of hypersensitivity to diclofenac or diclofenac-containing products
  • A history of intolerance to acetaminophen (rescue medication in this trial)
  • A history of skin sensitivity to adhesives (e.g. adhesive tape)
  • Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
  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: NCT00640705

Locations
United States, Texas
PPD
Austin, Texas, United States, 78744
Sponsors and Collaborators
Cerimon Pharmaceuticals
PPD
Investigators
Study Director: Dan Levitt, MD Cerimon Pharmaceuticals
  More Information

No publications provided

Responsible Party: Dan Levitt, MD, Cerimon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00640705     History of Changes
Other Study ID Numbers: DCF-002
Study First Received: March 18, 2008
Last Updated: September 3, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Ankle Injuries
Leg 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 October 19, 2014