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Sponsors and Collaborators: |
Transdel Pharmaceuticals Cato Research |
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Information provided by: | Transdel Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00765700 |
Transdel 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 |
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Sprain Strain |
Drug: ketoprofen Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
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. |
Estimated Enrollment: | 350 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Topical ketoprofen 10% Cream
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Drug: ketoprofen
Drug: ketoprofen 100 mg (10%) in 1 gram of proprietary topical cream; applied three times a day
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B: Placebo Comparator
Topical cream identical in appearance to active comparator, except without ketoprofen
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Drug: Placebo
Drug: Matching placebo cream (1 gram), containing identical constituents to the active comparator except for ketoprofen; applied three times a day
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Transdel 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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Medications (drugs) or other substances contraindicated due to the nature of study medication that include:
Contact: CATO Research | 858-452-7271 |
United States, North Carolina | |
CATO Research | Recruiting |
Durham, North Carolina, United States, 27713 |
Study Director: | Illana Katsnelson, MD | Cato Research |
Responsible Party: | Transdel Pharmaceuticals, Inc ( Paul Finnegan, MD ) |
Study ID Numbers: | TDLP-110-101 |
Study First Received: | October 1, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00765700 |
Health Authority: | United States: Food and Drug Administration |
Sprain Strain Pain Ankle Pain Shoulder Pain Elbow Pain |
Tennis Elbow Knee pain Wrist Pain Hand Pain Muscle, Bone and Cartilage Disorders |
Ketoprofen Soft Tissue Injuries Tennis Elbow Shoulder Pain |
Wounds and Injuries Disorders of Environmental Origin Pain Sprains and Strains |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |