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HKT-500 in Adult Patients With Shoulder Pain

This study has been completed.
Sponsor:
Information provided by:
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT00680472
First received: May 16, 2008
Last updated: October 28, 2008
Last verified: October 2008
History of Changes
  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:

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

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

  Show 35 Study Locations
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
Investigators
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
  More Information

No publications provided

Responsible Party: Mr. Kenichi Furuta, General Manager, International Development Dept., 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: October 28, 2008
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
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 June 18, 2013