A Phase 1 interventional study of AGG-523 (Aggrecanase Inhibitor) in Osteoarthritis, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 5 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2009-07-29.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 2 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.
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Exclusion Criteria:
AGG-523 1800 mg QD PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)
AGG-523 900 mg BID PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)
Placebo QD PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)
Placebo BID PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)
Using parts of the knee joint and the surrounding fluid that is taken out at the time of knee replacement, measure 1) the activity of aggrecansase (an enzyme that breaks down cartilage) and 2) the amount of study drug using lab tests.
Time frame: 4 weeks
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Wyeth is now a wholly owned subsidiary of Pfizer