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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: AGG-523 (Aggrecanase Inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454298

3189A1-106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 4 patient groups, including a placebo group

A

Active Comparator group

Description:

AGG-523 1800 mg QD PO (12 capsules) for 28 days

Treatment:

Drug: AGG-523 (Aggrecanase Inhibitor)

B

Active Comparator group

Description:

AGG-523 900 mg BID PO (12 capsules) for 28 days

Treatment:

Drug: AGG-523 (Aggrecanase Inhibitor)

C

Placebo Comparator group

Description:

Placebo QD PO (12 capsules) for 28 days

Treatment:

Drug: AGG-523 (Aggrecanase Inhibitor)

D

Placebo Comparator group

Description:

Placebo BID PO (12 capsules) for 28 days

Treatment:

Drug: AGG-523 (Aggrecanase Inhibitor)