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HKT-500-US12 In Adult Patients With OA Knee Pain
This study has been completed.
Study NCT00647231   Information provided by Hisamitsu Pharmaceutical Co., Inc.
First Received: March 26, 2008   Last Updated: August 11, 2008   History of Changes

March 26, 2008
August 11, 2008
March 2008
August 2008   (final data collection date for primary outcome measure)
Time to Onset and Duration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647231 on ClinicalTrials.gov Archive Site
Outcome Time Frame [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
Same as current
 
HKT-500-US12 In Adult Patients With OA Knee Pain
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

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

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

Phase II
Interventional
Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment
Osteoarthritis, Knee
Drug: HKT-500 Topical Patch
Experimental: A Randomized,Multi-Center, Double-Blind, Single Dose,
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00647231
Mr. Kenichi Furuta, General Manager, International Development Dept., Hisamitsu Pharmaceutical Co., Inc.
HKT-500-US12
Hisamitsu Pharmaceutical Co., Inc.
 
Study Director: Kenichi Furuta Hisamitsu
Hisamitsu Pharmaceutical Co., Inc.
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP