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| Descriptive Information Fields | |||||
| Brief Title † | HKT-500-US12 In Adult Patients With OA Knee Pain | ||||
| 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 | ||||
| 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 |
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| 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 |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment | ||||
| Primary Outcome Measure † | Time to Onset and Duration [ Time Frame: 36 hours ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Outcome Time Frame [ Time Frame: 36 hours ] [ Designated as safety issue: No ] | ||||
| Condition † | Osteoarthritis, Knee | ||||
| Intervention † | Drug: HKT-500 Topical Patch | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 300 | ||||
| Start Date † | March 2008 | ||||
| Completion Date | August 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00647231 | ||||
| Organization ID | HKT-500-US12 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Hisamitsu Pharmaceutical Co., Inc. | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Hisamitsu Pharmaceutical Co., Inc. | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | March 26, 2008 | ||||
| Last Updated Date | August 11, 2008 | ||||