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Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

NCT ID: NCT00941746

Last Updated: 2011-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lowest dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Second dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Third dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Fourth dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Fifth dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Top dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Placebo

single, slow intravenous infusion that matches PG110 in appearance

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

Single, slow intravenous infusion that matches PG110 in appearance

Seventh Dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Eight Dose of PG110

single, slow intravenous infusion

Group Type EXPERIMENTAL

PG110

Intervention Type BIOLOGICAL

Single, slow intravenous infusion

Interventions

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PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

PG110

Single, slow intravenous infusion

Intervention Type BIOLOGICAL

Placebo

Single, slow intravenous infusion that matches PG110 in appearance

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Jerry Hall, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Ref # / Investigator 51568

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2008-006219-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PG110-01

Identifier Type: -

Identifier Source: org_study_id

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