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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014