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Sponsored by: |
Wyeth |
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00454298 |
The main purpose of the study is to find out if, after 4 weeks of dosing, signs of the investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee joint. A secondary purpose is to evaluate the safety of taking the drug either once a day or twice a day for 4 weeks.
Condition | Intervention | Phase |
Osteoarthritis |
Drug: AGG-523 (Aggrecanase Inhibitor) |
Phase I |
MedlinePlus related topics: | Knee Replacement Osteoarthritis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Regimen, Parallel-Group Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AGG-523 Administered Orally to Subjects With Severe Osteoarthritis |
Estimated Enrollment: | 80 |
Study Start Date: | May 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Active Comparator
AGG-523 1800 mg QD PO (12 capsules) for 28 days
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Drug: AGG-523 (Aggrecanase Inhibitor) |
B: Active Comparator
AGG-523 900 mg BID PO (12 capsules) for 28 days
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Drug: AGG-523 (Aggrecanase Inhibitor) |
C: Placebo Comparator
Placebo QD PO (12 capsules) for 28 days
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Drug: AGG-523 (Aggrecanase Inhibitor) |
D: Placebo Comparator
Placebo BID PO (12 capsules) for 28 days
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Drug: AGG-523 (Aggrecanase Inhibitor) |
This is a multicenter study of 2 dosing regimens of AGG-523, an investigational aggrecanase inhibitor that is taken orally. Potential study subjects are those with severe Osteoarthritis (OA) of the knee who are scheduled to undergo total joint replacement surgery.
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).
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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |||||
Newton, Massachusetts, United States, 02462 | |||||
Boston, Massachusetts, United States, 02120 | |||||
Boston, Massachusetts, United States, 02215 | |||||
Winchester, Massachusetts, United States, 01801 | |||||
Worcester, Massachusetts, United States, 01655 |
Wyeth |
Study Director: | Medical Montior | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3189A1-106 |
First Received: | March 29, 2007 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00454298 |
Health Authority: | United States: Food and Drug Administration |
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