NCT00427687

Brief Summary

This study will evaluate the effect of AGG-523 administration on biomarkers related to osteoarthritis. Safety and tolerability of AGG-523 will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

3 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

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 5, 2008

Status Verified

August 1, 2008

First QC Date

January 25, 2007

Last Update Submit

August 1, 2008

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • The effect of AGG-523 on biomarkers related to osteoarthritis.

Interventions

AGG-523DRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate Osteoarthritis of the target knee.
  • Subjects must be generally healthy but enrolled with stable chronic illness if well controlled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

Altoona, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

February 1, 2007

Study Completion

June 1, 2007

Last Updated

August 5, 2008

Record last verified: 2008-08

Locations

US(3)