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HKT-500-US12 In Adult Patients With OA Knee Pain
This study has been completed.
First Received: March 26, 2008   Last Updated: August 11, 2008   History of Changes
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:


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

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 27, 2009