Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.

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Detailed Description

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Conditions

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Osteoarthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

MEDI-578

Intervention Type DRUG

intravenous infusion, once

2

Group Type PLACEBO_COMPARATOR

Placebo for MEDI-578

Intervention Type DRUG

Intravenous infusion, once

Interventions

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MEDI-578

intravenous infusion, once

Intervention Type DRUG

Placebo for MEDI-578

Intravenous infusion, once

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with painful osteoarthritis of the knee.
* The pain from the knee must exceed pain experienced from any other condition.
* Patients must be willing and able to discontinue all current analgesic treatment.

Exclusion Criteria

* Any other form of arthritis than osteoarthritis.
* Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis.
* Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No