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HKT-500-US12 In Adult Patients With OA Knee Pain

This study has been completed.
Sponsor:
Information provided by:
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT00647231
First received: March 26, 2008
Last updated: August 11, 2008
Last verified: August 2008
History of Changes
  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 2

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 June 18, 2013