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

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ClinicalTrials.gov Identifier: NCT00647231
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: HKT-500 Topical Patch Other: Placebo Patch Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Ketoprofen
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A, 2, II, HKT-500 Topical Patch
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
Drug: HKT-500 Topical Patch
Treatment with Ketoprofen Topical Patch
Other Names:
  • HKT-500
  • Ketoprofen
Placebo Comparator: Placebo Patch
Treatment with placebo patch
Other: Placebo Patch
Treatment with placebo patch
Other Name: Sham tratment



Primary Outcome Measures :
  1. Time to Onset and Duration [ Time Frame: 36 hours ]

Secondary Outcome Measures :
  1. Outcome Time Frame [ Time Frame: 36 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647231


  Show 29 Study Locations
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
Investigators
Study Director: Kenichi Furuta Hisamitsu

Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier: NCT00647231     History of Changes
Other Study ID Numbers: HKT-500-US12
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action