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Sponsored by: |
Hisamitsu Pharmaceutical Co., Inc. |
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Information provided by: | Hisamitsu Pharmaceutical Co., Inc. |
ClinicalTrials.gov Identifier: | NCT00680472 |
The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain
Condition | Intervention | Phase |
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Pain |
Drug: HKT-500 & Ketoprofen Topical Patch Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Protocol HKT-500-US08: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Acute Shoulder Pain |
Enrollment: | 368 |
Study Start Date: | April 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A,1,: Placebo Comparator
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects with Acute Shoulder Pain
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Drug: placebo
placebo
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A,2: Experimental |
Drug: HKT-500 & Ketoprofen Topical Patch
HKT-500 Topical Patch
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Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Kenichi Furuta | Hisamitsu Pharmaceutical Co., Inc. |
Responsible Party: | Hisamitsu Pharmaceutical Co., Inc ( Mr. Kenichi Furuta, General Manager, International Development Dept. ) |
Study ID Numbers: | HKT-500-US08 |
Study First Received: | May 16, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00680472 |
Health Authority: | United States: Food and Drug Administration |
Shoulder pain Pain Ketoprofen Topical Patch |
Ketoprofen Signs and Symptoms Musculoskeletal Diseases Shoulder Pain |
Joint Diseases Pain Arthralgia |
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 |