Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00454298
First received: March 29, 2007
Last updated: July 28, 2009
Last verified: July 2009
  Purpose

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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2
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
Active Comparator: A
AGG-523 1800 mg QD PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)
Active Comparator: B
AGG-523 900 mg BID PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)
Placebo Comparator: C
Placebo QD PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)
Placebo Comparator: D
Placebo BID PO (12 capsules) for 28 days
Drug: AGG-523 (Aggrecanase Inhibitor)

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454298

Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02120
Boston, Massachusetts, United States, 02215
Newton, Massachusetts, United States, 02462
Winchester, Massachusetts, United States, 01801
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Montior Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00454298     History of Changes
Other Study ID Numbers: 3189A1-106
Study First Received: March 29, 2007
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Severe Osteoarthritis
Arthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014