NCT00351104

Brief Summary

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

June 30, 2006

Last Update Submit

February 17, 2020

Conditions

SprainStrain

Keywords

SprainStrainPainAnkle PainMuscle, Bone and Cartilage Disorders

Outcome Measures

Primary Outcomes (1)

  • Average pain intensity during daily activities

Secondary Outcomes (1)

  • Average pain intensity while at rest; Functional disability; Use of rescue medication; Quality of sleep; Patient's and physician's global assessments of study medication

Interventions

Ketoprofen Topical Patch 20%DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females 18 years of age or older
  • Diagnosis of Grade I or Grade II ankle sprain or strain
  • Meet pain entry criteria
  • Willing to discontinue use of any pain medication not provided as part of the study

You may not qualify if:

  • Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain.
  • Have received corticosteroids in the 30 days preceding screening
  • Have a history or physical examination finding that is incompatible with safe participation in the study
  • Have a history or physical examination finding that is incompatible with study product use
  • Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
  • Are taking medications that may significantly affect renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

Sprains and StrainsPainCartilage Diseases

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • PPD

    PPD Austin, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 12, 2006

Study Start

June 1, 2006

Primary Completion

February 1, 2007

Study Completion

March 1, 2007

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

US(1)