Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement
NCT ID: NCT00454298
Last Updated: 2009-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2007-05-31
2008-03-31
Brief Summary
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Detailed Description
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Study subjects will be randomly assigned to 1 of 2 dosing regimens (once-daily or twice-daily dosing) of either 1800 mg AGG-523 or placebo, which will be taken during the 4-week period before having the total knee replacement. The treatments will be assigned using a 4:1 ratio of active to placebo treatment, which means that more subjects will receive the active treatment than the placebo (see below).
* AGG-523 1800 mg once a day (32 subjects)
* AGG-523 900 mg twice a day (32 subjects)
* Placebo once a day (8 subjects)
* Placebo twice a day (8 subjects)
Study subjects will have weekly evaluations as outpatients during the 4-week dosing period. The purpose of these evaluations is to monitor for potential complications, ensure compliance with taking the study drug, ask about the use of other medications, and, when necessary, replenish the supply of study drug. These assessments may be conducted by telephone, as a home visit, or by having the subject travel to the clinic for an outpatient office visit. A final (in person) visit will happen 2 weeks after having total knee replacement surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
AGG-523 1800 mg QD PO (12 capsules) for 28 days
AGG-523 (Aggrecanase Inhibitor)
B
AGG-523 900 mg BID PO (12 capsules) for 28 days
AGG-523 (Aggrecanase Inhibitor)
C
Placebo QD PO (12 capsules) for 28 days
AGG-523 (Aggrecanase Inhibitor)
D
Placebo BID PO (12 capsules) for 28 days
AGG-523 (Aggrecanase Inhibitor)
Interventions
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AGG-523 (Aggrecanase Inhibitor)
Eligibility Criteria
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Inclusion Criteria
* Osteoarthritis of the knee requiring total knee replacement surgery
Exclusion Criteria
* Recent major surgery (in past 3 months)
* Recent knee injections (in past 6 months)
55 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Montior
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Boston, Massachusetts, United States
Boston, Massachusetts, United States
Newton, Massachusetts, United States
Winchester, Massachusetts, United States
Worcester, Massachusetts, United States
Countries
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Other Identifiers
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3189A1-106
Identifier Type: -
Identifier Source: org_study_id
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