Clincosm LogoSign in Get a demo

Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00941746
Collaborator
(none)
56
Enrollment
1
Location
9
Arms
17
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: PG110
  • Biological: PG110
  • Biological: PG110
  • Biological: PG110
  • Biological: PG110
  • Biological: PG110
  • Biological: PG110
  • Biological: PG110
  • Biological: Placebo
 Phase 1

Study Design

Study Type:
Interventional
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 :
Aug 1, 2009
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The number and severity of adverse events [Three months]

Secondary Outcome Measures

  1. Terminal elimination half-life [Three months]

  2. Dose proportionality of the area under the serum concentration-time curve [Three months]

  3. Pain in the index knee [Three months]

  4. Western Ontario and McMaster Universities questionnaire [Three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Site Ref # / Investigator 51568 Utrecht Netherlands 3584 CJ

Sponsors and Collaborators

  • Abbott

Investigators

  • Study Director: Jerry Hall, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00941746
Other Study ID Numbers:
  • PG110-01
  • 2008-006219-19
First Posted:
Jul 20, 2009
Last Update Posted:
Jun 7, 2011
Last Verified:
May 1, 2011
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Jun 7, 2011