MedDataX Logo

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

NCT ID: NCT00640705

Last Updated: 2008-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Sprain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Topical diclofenac sodium patch

Group Type ACTIVE_COMPARATOR

diclofenac sodium

Intervention Type DRUG

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

B

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

Group Type PLACEBO_COMPARATOR

Matching placebo patch

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

diclofenac sodium

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

diclofenac placebo comparator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Cerimon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cerimon Pharmaceuticals, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dan Levitt, MD

Role: STUDY_DIRECTOR

Cerimon Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PPD

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DCF-002

Identifier Type: -

Identifier Source: org_study_id