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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01072591
• Other study ID #: D2460C00001
• Status: Terminated
• Phase: Phase 1
• First received: February 19, 2010
• Last updated: January 28, 2013
• Start date: February 2010
• Est. completion date: September 2010

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Drug:
• MEDI-578
intravenous infusion, once
• Placebo for MEDI-578
Intravenous infusion, once

Locations

Country	Name	City	State
United Kingdom	Research Site	London Bridge	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (adverse events, vital signs, ECG, safety lab)		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.	Yes
Secondary	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.	No
Secondary	To assess the immunogenicity of MEDI-578		Blood samples taken fortnightly from Day 1 until week 12.	No
Secondary	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.	No