Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941746
• Other study ID #: PG110-01
• Secondary ID: 2008-006219-19
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2009
• Last updated: June 3, 2011
• Start date: August 2009
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• PG110
Single, slow intravenous infusion
• PG110
Single, slow intravenous infusion
• PG110
Single, slow intravenous infusion
• PG110
Single, slow intravenous infusion
• PG110
Single, slow intravenous infusion
• PG110
Single, slow intravenous infusion
• PG110
Single, slow intravenous infusion
• PG110
Single, slow intravenous infusion
• Placebo
Single, slow intravenous infusion that matches PG110 in appearance

Locations

Country	Name	City	State
Netherlands	Site Ref # / Investigator 51568	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and severity of adverse events		Three months	Yes
Secondary	Terminal elimination half-life		Three months	No
Secondary	Dose proportionality of the area under the serum concentration-time curve		Three months	No
Secondary	Pain in the index knee		Three months	No
Secondary	Western Ontario and McMaster Universities questionnaire		Three months	No