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

Sponsor

Imprimis Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00765700

Collaborator

Cato Research (Industry)

364

Enrollment

Location

Arms

Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sprain Strain Acute Soft Tissue Injury	Drug: Topical Ketoprofen 10% Cream Drug: Topical Placebo Cream	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

364 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketoprofen 10% Cream Topical Ketoprofen 10% Cream 1gram three times daily for 7 days	Drug: Topical Ketoprofen 10% Cream Topical Administration Other Names: Ketotransdel (TDLP-110)
Placebo Comparator: Placebo Topical placebo cream 1gram three times daily for 7 days	Drug: Topical Placebo Cream Topical Administration Other Names: Placebo Vehicle

Arm

Intervention/Treatment

Active Comparator: Ketoprofen 10% Cream

Topical Ketoprofen 10% Cream 1gram three times daily for 7 days

Drug: Topical Ketoprofen 10% Cream

Topical Administration

Other Names:

Ketotransdel (TDLP-110)

Placebo Comparator: Placebo

Topical placebo cream 1gram three times daily for 7 days

Drug: Topical Placebo Cream

Topical Administration

Other Names:

Placebo

Vehicle

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Other Outcome Measures

To assess the pharmacokinetics of ketoprofen after 7 days of topical application [8 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.