NCT00454298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2007

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 29, 2009

Status Verified

July 1, 2009

Enrollment Period

10 months

First QC Date

March 29, 2007

Last Update Submit

July 28, 2009

Conditions

Osteoarthritis

Keywords

Severe OsteoarthritisArthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Study Arms (4)

A

ACTIVE COMPARATOR

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

Drug: AGG-523 (Aggrecanase Inhibitor)

B

ACTIVE COMPARATOR

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

Drug: AGG-523 (Aggrecanase Inhibitor)

C

PLACEBO COMPARATOR

Placebo QD PO (12 capsules) for 28 days

Drug: AGG-523 (Aggrecanase Inhibitor)

D

PLACEBO COMPARATOR

Placebo BID PO (12 capsules) for 28 days

Drug: AGG-523 (Aggrecanase Inhibitor)

Interventions

AGG-523 (Aggrecanase Inhibitor)DRUG
ABCD

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Other types of arthritis, like rheumatoid arthritis
  • Recent major surgery (in past 3 months)
  • Recent knee injections (in past 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Boston, Massachusetts, 02120, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Newton, Massachusetts, 02462, United States

Location

Unknown Facility

Winchester, Massachusetts, 01801, United States

Location

Unknown Facility

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Medical Montior

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2007

First Posted

March 30, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 29, 2009

Record last verified: 2009-07

Locations

US(5)