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

NCT01223053 | Withdrawn Phase 3

• 1 other identifier: TDLP-110-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Sprain; Strain; Pain; Ankle Pain; Knee Pain; Wrist Pain; Hand Pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean pain intensity (100 mm VAS) during daily activities over the past 24 hours at the Day 3 visit (Day 3 +1)

  3 days

Secondary Outcomes (1)

• CPRA; Pain curves over time; Percent change from baseline

  7 days

Study Arms (2)

Active

ACTIVE COMPARATOR

Topical ketoprofen 10% Cream

Drug: Ketoprofen 10% cream

Placebo Cream

PLACEBO COMPARATOR

Placebo Cream

Drug: Placebo

Interventions

Ketoprofen 10% cream DRUG

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

Also known as: TDLP-110, Ketotransdel

Active

Placebo DRUG

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

Placebo Cream

Eligibility Criteria

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

You may qualify if:

• Are male or female and 18 to 75 years of age, inclusive.
• Female patients of childbearing potential must practice abstinence or be using a medically acceptable form of contraception
• Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 or Grade 2 sprain or strain), that has occurred within the 60 hours preceding the baseline visit.
• Meet pain intensity criteria
• Are willing to discontinue use of any pain medication or treatments not provided as part of the study.

You may not qualify if:

• Participation in a previous clinical study with the drug TDLP-110 (ketoprofen 10% cream).
• Are pregnant or lactating.
• Have a Grade 3 sprain or strain, bilateral sprain or strain, or concomitant fracture or open wound at the site of the sprain or strain, or have a serious injury, as determined by the investigator
• Have a shoulder (rotator cuff) injury.
• Have been treated for a sprain or strain of the same site within the past 3 months.
• Have contusions at the site of acute soft tissue injury intended for treatment.
• Have active skin lesions or disease at the intended site of application of the study medication.
• Have had pharmacologic treatment for the injury less than 24 hours before the baseline assessments
• Use of any oral or parenteral corticosteroids within 30 days of injury.
• Have had non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) within 12 hours prior to the baseline visit.
• 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, in the opinion of the investigator, incompatible with study product use or with obtaining interpretable data.
• Are taking medications or other substances contraindicated due to the nature of the study medication or with the potential for drug interactions.
• Are allergic or sensitive to soy lecithin or soy lecithin-containing products.
• Are taking probenecid or similar drugs that may significantly affect renal function.

Sponsors & Collaborators

• Imprimis Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Sprains and Strains; Pain

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 18, 2010
• Last Updated: September 5, 2012

Record last verified: 2012-09