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

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

MedlinePlus related topics:

Osteoarthritis

ChemIDplus related topics:

Ketoprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, 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

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

Show 29 Study Locations

Sponsors and Collaborators

Hisamitsu Pharmaceutical Co., Inc.

Investigators


Study Director:	Kenichi Furuta	Hisamitsu

More Information

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

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic

Study placed in the following topic categories:

Ketoprofen

Osteoarthritis, Knee

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Pain

Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 04, 2008

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