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Trial record 1 of 1 for:    NCT00454298
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Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454298
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : July 29, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE March 29, 2007
First Posted Date  ICMJE March 30, 2007
Last Update Posted Date July 29, 2009
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2007)
Using parts of the knee joint and the surrounding fluid that is taken out at the time of knee replacment, measure 1) the activity of aggrecansase (an enzyme that breaks down cartilage) and 2) the amount of study drug using lab tests.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement
Official Title  ICMJE 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
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Drug: AGG-523 (Aggrecanase Inhibitor)
Study Arms  ICMJE
  • Active Comparator: A
    AGG-523 1800 mg QD PO (12 capsules) for 28 days
    Intervention: Drug: AGG-523 (Aggrecanase Inhibitor)
  • Active Comparator: B
    AGG-523 900 mg BID PO (12 capsules) for 28 days
    Intervention: Drug: AGG-523 (Aggrecanase Inhibitor)
  • Placebo Comparator: C
    Placebo QD PO (12 capsules) for 28 days
    Intervention: Drug: AGG-523 (Aggrecanase Inhibitor)
  • Placebo Comparator: D
    Placebo BID PO (12 capsules) for 28 days
    Intervention: Drug: AGG-523 (Aggrecanase Inhibitor)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2009)
2
Original Enrollment  ICMJE
 (submitted: March 29, 2007)
80
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy, men or women, at least 55 years old
  • Osteoarthritis of the knee requiring total knee replacement surgery

Exclusion Criteria:

  • Other types of arthritis, like rheumatoid arthritis
  • Recent major surgery (in past 3 months)
  • Recent knee injections (in past 6 months)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00454298
Other Study ID Numbers  ICMJE 3189A1-106
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Montior Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP