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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Boston, Massachusetts, 02120 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Generally healthy, men or women, at least 55 years old

- Osteoarthritis of the knee requiring total knee replacement surgery

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Other types of arthritis, like rheumatoid arthritis

- Recent major surgery (in past 3 months)

- Recent knee injections (in past 6 months)

NCT00454298
Pfizer
Completed
Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement

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

  • 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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis
Drug: AGG-523 (Aggrecanase Inhibitor)
  • 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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
March 2008
March 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00454298
3189A1-106
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Montior Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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