Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Phase 1

Completed

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT00941746
• Lead Sponsor: Abbott

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Study Start: 2009-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-05
• Last Update Submitted: 2011-06-03
• Last Update Posted: 2011-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The number and severity of adverse events	Three months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Site Ref # / Investigator 51568; 🇳🇱 Utrecht, Netherlands