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

AstraZeneca1 site in 1 country108 target enrollmentFebruary 2010

ConditionsOsteoarthritis Pain

InterventionsMEDI-578 Placebo for MEDI-578

DrugsMEDI-578 Placebo for MEDI-578

Overview

Phase: Phase 1
Intervention: MEDI-578
Conditions: Osteoarthritis
Sponsor: AstraZeneca
Enrollment: 108
Locations: 1
Primary Endpoint: Safety variables (adverse events, vital signs, ECG, safety lab)
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

September 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: MEDI-578

2

Intervention: Placebo for MEDI-578

Outcomes

Primary Outcomes

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.

Secondary Outcomes

To characterize the pharmacokinetics of MEDI-578 in plasma.(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(Blood samples taken fortnightly from Day 1 until week 12.)
To evaluate the analgesic efficacy of MEDI-578 during the night and day.(Patients will record their pain intensity every morning and evening during the 13 weeks study period.)