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
2 other identifiers
interventional
56
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 20, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJune 7, 2011
May 1, 2011
1.4 years
July 14, 2009
June 3, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The number and severity of adverse events
Three months
Secondary Outcomes (4)
Terminal elimination half-life
Three months
Dose proportionality of the area under the serum concentration-time curve
Three months
Pain in the index knee
Three months
Western Ontario and McMaster Universities questionnaire
Three months
Study Arms (9)
Lowest dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Second dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Third dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Fourth dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Fifth dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Top dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Placebo
EXPERIMENTALsingle, slow intravenous infusion that matches PG110 in appearance
Seventh Dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Eight Dose of PG110
EXPERIMENTALsingle, slow intravenous infusion
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to severe pain attributed to knee osteoarthritis
You may not qualify if:
- Significant comorbidity
- Significant pain states other than osteoarthritis
- Concomitant medications that might affect assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (1)
Site Ref # / Investigator 51568
Utrecht, 3584 CJ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jerry Hall, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 20, 2009
Study Start
August 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
June 7, 2011
Record last verified: 2011-05