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

Sprain Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdel™ (Ketoprofen Topical Cream 10%) in the Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765700
• Other study ID #: TDLP-110-101
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2008
• Last updated: September 20, 2013
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2013
• Source: Imprimis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.

Description:

The primary objective of this study is to determine the efficacy and safety of ketoprofen 10% cream compared to placebo as a three-times-per-day topical application in improving the patient assessment of pain when used to treat mild to moderate acute soft tissue injury of the upper and lower extremities over a 7-day period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 to 70 years of age

• Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity that has occurred within the 72 hours preceding the baseline visit.

• The injury site must be accessible to the patient so that he or she can apply the study treatment himself or herself.

• Meet pain entry criteria.

• Willing to discontinue use of any pain medication or treatments not provided as part of the study.

Exclusion Criteria:

• 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 (e.g., nerve damage, joint instability, or tendon rupture).

• Previous injury to the same area within 3 months prior to current injury.

• Active skin lesions or disease at the intended site of application of the study medication. Skin lesions include open wounds, rash, papules, vesicles, and erythema associated with the site of injury.

• Pharmacologic treatment (NSAIDs or analgesic medications) for the injury less than 12 hours before the baseline assessments.

• Any form of opioid use since the time of injury.

• Any form of steroid use within 30 days prior to study entry.

• Non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) prior to the baseline visit.

• History or physical examination finding that is not compatible with safe participation in the study as determined by the study doctor, such as gastrointestinal (stomach, intestine) ulcer or bleeding within 6 months documented by an upper-gastrointestinal series (UGI x-ray, barium meal) or endoscopy (GI scope), anemia or abnormal bleeding, moderate to severe kidney disease, or moderate to severe liver disease.

• A history of, or evidence for, underlying disease in the injured area, such as osteoarthritis or gout.

• Clinically significant, poorly controlled lung, stomach, liver, kidney, heart, or other vital organ disease as determined by the study doctor or nurse.

• A history of allergy to ketoprofen or ketoprofen-containing products.

• A history of allergy to soy lecithin or soy lecithin-containing products.

• Medications (drugs) or other substances contraindicated due to the nature of study medication that include:

• Allergies to prescription or over-the-counter products containing acetaminophen (e.g., Tylenol®), which is used as rescue medication

• History of aspirin-sensitive asthma, or aspirin-associated rhinitis or nasal polyps

• Taking warfarin, parenteral heparin, ticlopidine or clopidogrel

• Taking lithium or methotrexate

• Taking probenecid or similar drugs that might affect the kidneys

• Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication.

• Scheduled elective surgery or other invasive procedures during the period of study participation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Soft Tissue Injury
• Soft Tissue Injuries
• Sprain
• Strain

Intervention

Drug:
• Topical Ketoprofen 10% Cream
Topical Administration
• Topical Placebo Cream
Topical Administration

Locations

Country	Name	City	State
United States	CATO Research	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Imprimis Pharmaceuticals, Inc.	Cato Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

E. Ekman, S. Skrepnik, M. Jones , K. Lawson, and J. Schupp. EFFICACY AND SAFETY OF KETOPROFEN 10% CREAM IN ACUTE SOFT TISSUE INJURIES (PHASE 3 STUDY TDLP-110-001). Poster Presentation, Sep. 2, 2010, 13th World Congress on Pain in Montreal, Canada.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the pharmacokinetics of ketoprofen after 7 days of topical application		8 days	No
Primary	Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit.		7 days	No
Secondary	Assess the safety, tolerability and other parameters of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury of upper and lower extremities.		14 days	No