Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

NCT00640705 | Terminated Phase 2

• 1 other identifier: DCF-002
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Sprain

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.

  7 days

Secondary Outcomes (1)

• Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.

  7 days

Study Arms (2)

A

ACTIVE COMPARATOR

Topical diclofenac sodium patch

Drug: diclofenac sodium

B

PLACEBO COMPARATOR

Topical patch identical in appearance to active comparator, except without diclofenac sodium

Drug: Matching placebo patch

Interventions

diclofenac sodium DRUG

15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily

Also known as: diclofenac

A

Matching placebo patch DRUG

Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily

Also known as: placebo comparator

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerimon Pharmaceuticals: lead
• PPD Development, LP: collaborator

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dan Levitt, MD

  Cerimon Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 4, 2008

Record last verified: 2008-09

Locations

US (1)