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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
History of Changes

July 14, 2009
June 3, 2011
August 2009
January 2011   (final data collection date for primary outcome measure)
The number and severity of adverse events [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00941746 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain
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

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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • Biological: PG110
    Single, slow intravenous infusion
  • Biological: Placebo
    Single, slow intravenous infusion that matches PG110 in appearance
  • Experimental: Lowest dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
  • Experimental: Second dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
  • Experimental: Third dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
  • Experimental: Fourth dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
  • Experimental: Fifth dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
  • Experimental: Top dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
  • Experimental: Placebo
    single, slow intravenous infusion that matches PG110 in appearance
    Intervention: Biological: Placebo
  • Experimental: Seventh Dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
  • Experimental: Eight Dose of PG110
    single, slow intravenous infusion
    Intervention: Biological: PG110
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00941746
PG110-01, 2008-006219-19
No
Jerry A Hall, Medical Director, Abbott
Abbott
Not Provided
Study Director: Jerry Hall, MD Abbott
Abbott
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP