Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454298
Status:
COMPLETED
Last Update Posted:
2009-07-29
First Post:
2007-03-29
Brief Title:
Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 41 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
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 41 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None