Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00941746
First received: July 14, 2009
Last updated: June 3, 2011
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Osteoarthritis, Knee
Biological: PG110
Biological: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The number and severity of adverse events [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Terminal elimination half-life [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Dose proportionality of the area under the serum concentration-time curve [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Pain in the index knee [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Universities questionnaire [ Time Frame: Three months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lowest dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion
Experimental: Second dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion
Experimental: Third dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion
Experimental: Fourth dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion
Experimental: Fifth dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion
Experimental: Top dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion
Experimental: Placebo
single, slow intravenous infusion that matches PG110 in appearance
Biological: Placebo
Single, slow intravenous infusion that matches PG110 in appearance
Experimental: Seventh Dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion
Experimental: Eight Dose of PG110
single, slow intravenous infusion
Biological: PG110
Single, slow intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941746

Locations
Netherlands
Site Ref # / Investigator 51568
Utrecht, Netherlands, 3584 CJ
Sponsors and Collaborators
Abbott
Investigators
Study Director: Jerry Hall, MD Abbott
  More Information

No publications provided

Responsible Party: Jerry A Hall, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00941746     History of Changes
Other Study ID Numbers: PG110-01, 2008-006219-19
Study First Received: July 14, 2009
Last Updated: June 3, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014