Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: PG110; Biological: Placebo

• 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

Arm && Interventions

Group	Intervention	Description
Third dose of PG110	PG110	single, slow intravenous infusion
Lowest dose of PG110	PG110	single, slow intravenous infusion
Second dose of PG110	PG110	single, slow intravenous infusion
Fourth dose of PG110	PG110	single, slow intravenous infusion
Fifth dose of PG110	PG110	single, slow intravenous infusion
Top dose of PG110	PG110	single, slow intravenous infusion
Placebo	Placebo	single, slow intravenous infusion that matches PG110 in appearance
Seventh Dose of PG110	PG110	single, slow intravenous infusion
Eight Dose of PG110	PG110	single, slow intravenous infusion

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