HKT-500 in Adult Patients With Shoulder Pain (Pain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680472
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : June 4, 2015
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.

Brief Summary:
The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain

Condition or disease Intervention/treatment Phase
Pain Drug: HKT-500 Ketoprofen Topical Patch Other: Placebo Patch Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ketoprofen
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A,1 HKT-500 Ketoprofen Topical Patch
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
Drug: HKT-500 Ketoprofen Topical Patch
HKT-500 Ketoprofen Topical Patch
Other Name: Ketoprofen Topical Patch
Placebo Comparator: A,2 Placebo Patch
Treatment with placebo patch
Other: Placebo Patch
Treatment with Placebo Patch
Other Name: Sham treatment

Primary Outcome Measures :
  1. Pain Assessment [ Time Frame: 2 Weeks ]

Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject has unilateral acute shoulder pain.

Exclusion Criteria:

  • The subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680472

  Hide Study Locations
United States, Alabama
Hisamitsu Investigator Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Hisamitsu Investigator Site
Tempe, Arizona, United States, 85283
United States, California
Hisamitsu Investigator Site
Fullerton, California, United States, 92835
United States, Colorado
Hisamitsu Investigator Site
Denver, Colorado, United States, 80204
United States, District of Columbia
Hisamitsu Investigator Site
Washington, District of Columbia, United States, 20003
United States, Florida
Hisamitsu Investigator Site
Bradenton, Florida, United States, 34209
Hisamitsu Investigator Site
Chiefland, Florida, United States, 32626
Hisamitsu Investigator Site
DeLand, Florida, United States, 32720
Hisamitsu Investigator Site
Delray Beach, Florida, United States, 33484
Hisamitsu Investigator Site
Dunedin, Florida, United States, 34698
Hisamitsu Investigator Site
Longwood, Florida, United States, 32779
Hisamitsu Investigator Site
Oldsmar, Florida, United States, 34677
Hisamitsu Pharmaceutical Co., Inc.
Orange City, Florida, United States, 32763
Hisamitsu Investigator Site
Plantation, Florida, United States, 33324
Hisamitsu Investigator Site
Tampa, Florida, United States, 33603
Hisamitsu Investigator Site
Tampa, Florida, United States, 33609
United States, Georgia
Hisamitsu Investigator Site
Blue Ridge, Georgia, United States, 30513
United States, Idaho
Hisamitsu Investigator Site
Boise, Idaho, United States, 83702
United States, Kansas
Hisamitsu Investigator Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Hisamitsu Investigator Site
Paducah, Kentucky, United States, 42003
United States, Maryland
Hisamitsu Investigator Site
Bowie, Maryland, United States, 20716
United States, Michigan
Hisamitsu Investigator Site
Kalamazoo, Michigan, United States, 49009
United States, New Jersey
Hisamitsu Investigator Site
Bridgewater, New Jersey, United States, 08807
United States, North Carolina
Hisamitsu Investigator Site
Cary, North Carolina, United States, 27513
HIsamitsu Pharmaceutical Co., Inc.
Durham, North Carolina, United States, 27704
Hisamitsu Investigator Site
Raleigh, North Carolina, United States, 27615
United States, North Dakota
Hisamitsu Investigator Site
Fargo, North Dakota, United States, 58104
Hisamitsu Investigator Site
Fargo, North Dakota, United States, 58108
United States, Ohio
HIsamitsu Pharmaceutical Co., Inc.
Perrysburg, Ohio, United States, 43551
Hisamitsu Investigator Site
Toledo, Ohio, United States, 43623
Hisamitsu Investigator Site
Zanesville, Ohio, United States, 43701
United States, Tennessee
Hisamitsu Investigator Site
New Tazewell, Tennessee, United States, 37825
United States, Texas
Hisamitsu Investigator Site
Bryan, Texas, United States, 77802
Hisamitsu Investigator Site
San Antonio, Texas, United States, 78217
United States, Virginia
Hisamitsu Investigator Site
Newport News, Virginia, United States, 23606
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.

Responsible Party: Hisamitsu Pharmaceutical Co., Inc. Identifier: NCT00680472     History of Changes
Other Study ID Numbers: HKT-500-US08
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
Shoulder pain
Topical Patch

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action