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:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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
Experimental: A, 2, II A Randomized,Multi-Center, Double-Blind, Single Dose,	Drug: HKT-500 Topical Patch Ketoprofen Topical Patch HKT-500 Topical Patch Other Names: HKT-500 Ketoprofen

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

No publications provided

Responsible Party:	Mr. Kenichi Furuta, General Manager, International Development Dept., Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT00647231 History of Changes
Other Study ID Numbers:	HKT-500-US12
Study First Received:	March 26, 2008
Last Updated:	August 11, 2008
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:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Ketoprofen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012