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HKT-500 in Adult Patients With Shoulder Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT00680472
First received: May 16, 2008
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Pain
Drug: HKT-500 & Ketoprofen Topical Patch
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hisamitsu Pharmaceutical Co., Inc.:

Primary Outcome Measures:
  • Pain Assessment [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Assessment [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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
Placebo Comparator: A,1,
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: placebo
placebo
Other Name: HKT-500 Topical Patch
Experimental: A,2 Drug: HKT-500 & Ketoprofen Topical Patch
HKT-500 Topical Patch
Other Names:
  • Ketoprofen Topical Patch
  • HKT-500
  • Ketoprofen

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680472

  Hide Study Locations
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, 58108
Hisamitsu Investigator Site
Fargo, North Dakota, United States, 58104
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.
Investigators
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
  More Information

No publications provided

Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier: NCT00680472     History of Changes
Other Study ID Numbers: HKT-500-US08
Study First Received: May 16, 2008
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014