HKT-500 in Adult Patients With Shoulder Pain - Full Text View

Sponsored by:	Hisamitsu Pharmaceutical Co., Inc.
Information provided by:	Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT00680472

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 III

Drug Information available for: Ketoprofen

U.S. FDA Resources

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

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
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	Drug: placebo placebo
A,2: Experimental	Drug: HKT-500 & Ketoprofen Topical Patch HKT-500 Topical Patch

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:	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 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Shoulder pain
Pain
Ketoprofen
Topical Patch

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ketoprofen
Shoulder Pain
Joint Diseases
Cyclooxygenase Inhibitors
Pain
Signs and Symptoms

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Arthralgia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ketoprofen
Molecular Mechanisms of Pharmacological Action
Shoulder Pain
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pain
Pharmacologic Actions
Signs and Symptoms

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Arthralgia

ClinicalTrials.gov processed this record on May 07, 2009