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

This study has been completed.
Sponsor:
Collaborator:
Cato Research
Information provided by (Responsible Party):
Imprimis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00765700
First received: October 1, 2008
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Sprain
Strain
Acute Soft Tissue Injury
Drug: Topical Ketoprofen 10% Cream
Drug: Topical Placebo Cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Imprimis Pharmaceuticals, Inc.:

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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To assess the pharmacokinetics of ketoprofen after 7 days of topical application [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment: 364
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketoprofen 10% Cream

Topical Ketoprofen 10% Cream

1gram three times daily for 7 days

Drug: Topical Ketoprofen 10% Cream
Topical Administration
Other Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765700

Locations
United States, North Carolina
CATO Research
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Imprimis Pharmaceuticals, Inc.
Cato Research
Investigators
Study Director: Illana Katsnelson, MD Cato Research
  More Information

No publications provided

Responsible Party: Imprimis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00765700     History of Changes
Other Study ID Numbers: TDLP-110-101
Study First Received: October 1, 2008
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Imprimis Pharmaceuticals, Inc.:
Sprain
Strain
Pain
Ankle Pain
Shoulder Pain
Elbow Pain
Tennis Elbow
Knee pain
Wrist Pain
Hand Pain
Muscle, Bone and Cartilage Disorders

Additional relevant MeSH terms:
Soft Tissue Injuries
Sprains and Strains
Wounds and Injuries
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014