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Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

PG110

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Site Ref # / Investigator 51568

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

Lowest dose of PG110

Second dose of PG110

Third dose of PG110

Fourth dose of PG110

Fifth dose of PG110

Top dose of PG110

Placebo

Seventh Dose of PG110

Eight Dose of PG110

Arm Description

single, slow intravenous infusion

single, slow intravenous infusion that matches PG110 in appearance

single, slow intravenous infusion

Outcomes

Primary Outcome Measures

The number and severity of adverse events

Secondary Outcome Measures

Terminal elimination half-life

Dose proportionality of the area under the serum concentration-time curve

Pain in the index knee

Western Ontario and McMaster Universities questionnaire

Full Information

NCT ID

NCT00941746

First Posted

July 14, 2009

Last Updated

June 3, 2011

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00941746

Brief Title

Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

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 Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lowest dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Arm Title

Second dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Arm Title

Third dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Arm Title

Fourth dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Arm Title

Fifth dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Arm Title

Top dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Arm Title

Placebo

Arm Type

Experimental

Arm Description

single, slow intravenous infusion that matches PG110 in appearance

Arm Title

Seventh Dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Arm Title

Eight Dose of PG110

Arm Type

Experimental

Arm Description

single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

PG110

Intervention Description

Single, slow intravenous infusion

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Single, slow intravenous infusion that matches PG110 in appearance

Primary Outcome Measure Information:

Title

The number and severity of adverse events

Time Frame

Three months

Secondary Outcome Measure Information:

Title

Terminal elimination half-life

Time Frame

Three months

Title

Dose proportionality of the area under the serum concentration-time curve

Time Frame

Three months

Title

Pain in the index knee

Time Frame

Three months

Title

Western Ontario and McMaster Universities questionnaire

Time Frame

Three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerry Hall, MD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Site Ref # / Investigator 51568

City

Utrecht

ZIP/Postal Code

3584 CJ

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

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