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Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury

NCT01223053 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-09-05

No results posted yet for this study

Summary

Transdel Pharmaceuticals is investigating a topical cream formulation consisting of 10% ketoprofen for the local treatment of pain associated with mild to moderate acute soft tissue injury in this confirmatory Phase 3 trial.

Conditions

  • Sprain

Interventions

DRUG

Ketoprofen 10% cream

100 mg (10%) in 1 gram of topical cream applied three times per day for 7 days. Safety follow up on day 14.

DRUG

Placebo

Matching placebo cream containing identical constituents as the active comparator except for ketoprofen

Sponsors & Collaborators

  • Imprimis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01223053 on ClinicalTrials.gov