Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Abbott56 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

PG110BIOLOGICAL

Single, slow intravenous infusion

PG110BIOLOGICAL

Single, slow intravenous infusion

PG110BIOLOGICAL

Single, slow intravenous infusion

PG110

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Site Ref # / Investigator 51568

Utrecht, Netherlands

Outcomes

Primary Outcomes

The number and severity of adverse events

Time frame: Three months

Secondary Outcomes

Terminal elimination half-life

Time frame: Three months

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

Time frame: Three months

Pain in the index knee

Time frame: Three months

Western Ontario and McMaster Universities questionnaire

Time frame: Three months

Data from ClinicalTrials.gov

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