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Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Primary Purpose

Ankle Sprain

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

diclofenac sodium

Matching placebo patch

About this trial

This is an interventional treatment trial for Ankle Sprain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Topical diclofenac sodium patch

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00640705

First Posted

March 18, 2008

Last Updated

September 3, 2008

Sponsor

Cerimon Pharmaceuticals

Collaborators

PPD

1. Study Identification

Unique Protocol Identification Number

NCT00640705

Brief Title

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Cerimon Pharmaceuticals

Collaborators

PPD

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Sprain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Topical diclofenac sodium patch

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

diclofenac sodium

Other Intervention Name(s)

diclofenac

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Matching placebo patch

Other Intervention Name(s)

placebo comparator

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

7 days

Secondary Outcome Measure Information:

Title

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

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Levitt, MD

Organizational Affiliation

Cerimon Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

PPD

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

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