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Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT00941746
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : June 7, 2011
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: PG110 Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : August 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The number and severity of adverse events [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Terminal elimination half-life [ Time Frame: Three months ]
  2. Dose proportionality of the area under the serum concentration-time curve [ Time Frame: Three months ]
  3. Pain in the index knee [ Time Frame: Three months ]
  4. Western Ontario and McMaster Universities questionnaire [ Time Frame: Three months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941746


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

Responsible Party: Jerry A Hall, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00941746     History of Changes
Other Study ID Numbers: PG110-01
2008-006219-19 ( EudraCT Number )
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: May 2011

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