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

NCT00765700 | Completed Phase 3

• 1 other identifier: TDLP-110-101
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Sprain; Strain; Acute Soft Tissue Injury

Keywords

Sprain; Strain; Pain; Ankle Pain; Shoulder Pain; Elbow Pain; Tennis Elbow; Knee pain; Wrist Pain; Hand Pain; Muscle, Bone and Cartilage Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (1)

• To assess the pharmacokinetics of ketoprofen after 7 days of topical application

  8 days

Study Arms (2)

Ketoprofen 10% Cream

ACTIVE COMPARATOR

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

Drug: Topical Ketoprofen 10% Cream

Placebo

PLACEBO COMPARATOR

Topical placebo cream 1gram three times daily for 7 days

Drug: Topical Placebo Cream

Interventions

Topical Ketoprofen 10% Cream DRUG

Topical Administration

Also known as: Ketotransdel (TDLP-110)

Ketoprofen 10% Cream

Topical Placebo Cream DRUG

Topical Administration

Also known as: Placebo, Vehicle

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imprimis Pharmaceuticals, Inc.: lead
• Cato Research: collaborator

Study Sites (1)

CATO Research

Durham, North Carolina, 27713, United States

Location

Related 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.

  RESULT

MeSH Terms

Conditions

Sprains and Strains; Pain; Shoulder Pain; Tennis Elbow; Cartilage Diseases

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Elbow Injuries; Arm Injuries; Tendon Injuries; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Illana Katsnelson, MD

  Cato Research

  STUDY DIRECTOR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 27, 2013

Record last verified: 2013-09

Locations

US (1)