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OpenTrials
Completed

NCT Number: NCT00941746

Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

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).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Ref # / Investigator 51568

Utrecht, 3584 CJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PG110

Biological

Single, slow intravenous infusion

Placebo

Biological

Single, slow intravenous infusion that matches PG110 in appearance

Primary outcomes

  1. The number and severity of adverse events

    Time frame: Three months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2009
Registry last updated
Jun 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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