A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PG110 (Anti-NGF Monoclonal Antibody) in Patients With Pain Attributed to Osteoarthritis of the Knee

Abbott1 site in 1 country56 target enrollmentAugust 2009

ConditionsOsteoarthritis, Knee

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Abbott
Enrollment: 56
Locations: 1
Primary Endpoint: The number and severity of adverse events
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

January 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

Inclusion Criteria

•Moderate to severe pain attributed to knee osteoarthritis

Exclusion Criteria

•Significant comorbidity
•Significant pain states other than osteoarthritis
•Concomitant medications that might affect assessments

Outcomes

Primary Outcomes

The number and severity of adverse events

Time Frame: Three months

Secondary Outcomes

Terminal elimination half-life(Three months)
Dose proportionality of the area under the serum concentration-time curve(Three months)
Pain in the index knee(Three months)
Western Ontario and McMaster Universities questionnaire(Three months)