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

January 28, 2013 updated by: AstraZeneca

A Phase I, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess Safety,Tolerability, Pharmacokinetics and Efficacy of MEDI-578, an Anti-NGF Monoclonal Antibody, After Single Ascending Doses in Male and Non-fertile Female Patients With Painful Osteoarthritis of the Knee

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London Bridge, Greater London, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: MEDI-578
intravenous infusion, once
Placebo Comparator: 2
Drug: Placebo for MEDI-578
Intravenous infusion, once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety variables (adverse events, vital signs, ECG, safety lab)
Time Frame: Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.
Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12.

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the pharmacokinetics of MEDI-578 in plasma.
Time Frame: Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12.
Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12.
To assess the immunogenicity of MEDI-578
Time Frame: Blood samples taken fortnightly from Day 1 until week 12.
Blood samples taken fortnightly from Day 1 until week 12.
To evaluate the analgesic efficacy of MEDI-578 during the night and day.
Time Frame: Patients will record their pain intensity every morning and evening during the 13 weeks study period.
Patients will record their pain intensity every morning and evening during the 13 weeks study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

MedImmune LLC

Investigators

  • Study Director: Rolf Karlsten, AstraZeneca RD Södertälje

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2460C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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