HKT-500-US12 In Adult Patients With OA Knee Pain - Full Text View

Sponsor:	Hisamitsu Pharmaceutical Co., Inc.
Information provided by:	Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT00647231

Purpose

The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: HKT-500 Topical Patch	Phase II

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment
Official Title:	Protocol HKT-500-US12: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ketoprofen

U.S. FDA Resources

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

Primary Outcome Measures:

Time to Onset and Duration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Outcome Time Frame [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Enrollment:	300
Study Start Date:	March 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 2, II: Experimental A Randomized,Multi-Center, Double-Blind, Single Dose,	Drug: HKT-500 Topical Patch Ketoprofen Topical Patch HKT-500 Topical Patch

Detailed Description:

A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female 45 years of age or older
with osteoarthritis of the knee

Exclusion Criteria:

subject is a woman of childbearing potential
who has a positive urine pregnancy test,
is lactating, or who is not surgically sterile

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647231

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Locations

United States, Alabama
Hisamitsu Investigator Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Hisamitsu Investigator Site
Phoenix, Arizona, United States, 85013
United States, Arkansas
Hisamitsu Investigator Site
Little Rock, Arkansas, United States, 72205
Hisamitsu Investigator Site
Little Rock, Arkansas, United States, 72211
United States, California
Hisamitsu Investigator Site
Escondido, California, United States, 92025
Hisamitsu Investigator Site
Burbank, California, United States, 91505
Hisamitsu Investigator Site
Northridge, California, United States, 91325
United States, Colorado
Hisamitsu Investigator Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Hisamitsu Investigator Site
Ocala, Florida, United States, 34474
Hisamitsu Investigator Site
Deland, Florida, United States, 32720
Hisamitsu Investigator Site
Ormond Beach, Florida, United States, 32174
Hisamitsu Investigator Site
Hallandale Beach, Florida, United States, 33009
United States, Georgia
Hisamitsu Investigator Site
Savannah, Georgia, United States, 31405
Hisamitsu Investigator Site
Stockbridge, Georgia, United States, 30281
Hisamitsu Investigator Site
Austell, Georgia, United States, 30106
United States, Illinois
Hisamitsu Investigator Site
Chicago, Illinois, United States, 60616
United States, Kentucky
Hisamitsu Investigator Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Hisamitsu Investigator Site
Baton Rouge, Louisiana, United States, 70809
Hisamitsu Investigator Site
Lake Charles, Louisiana, United States, 70601
United States, Michigan
Hisamitsu Investigator Site
Flint, Michigan, United States, 48504
United States, Nebraska
Hisamitsu Investigator Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hisamitsu Investigator Site
Berlin, New Jersey, United States, 08009
United States, North Carolina
Hisamitsu Investigator Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Hisamitsu Investigator Site
Zanesville, Ohio, United States, 43701
Hisamitsu Investigator Site
Cincinnati, Ohio, United States, 45206
United States, Oklahoma
Hisamitsu Investigator Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Hisamitsu Investigator Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Hisamitsu Investigator Site
Houston, Texas, United States, 77074
United States, Utah
Hisamitsu Investigator Site
Salt Lake City, Utah, United States, 84108

Sponsors and Collaborators

Hisamitsu Pharmaceutical Co., Inc.

Investigators

Study Director:

Kenichi Furuta

Hisamitsu

More Information

No publications provided

Responsible Party:	Hisamitsu Pharmaceutical Co., Inc. ( Mr. Kenichi Furuta, General Manager, International Development Dept. )
Study ID Numbers:	HKT-500-US12
Study First Received:	March 26, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00647231 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ketoprofen
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Osteoarthritis, Knee

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

ClinicalTrials.gov processed this record on November 25, 2009