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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Osteoarthritis; Pain

Treatments: Drug: MEDI-578; Drug: Placebo for MEDI-578

Study type: Interventional

Funder types: Industry

Identifiers

NCT01072591

D2460C00001

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MEDI-578

2

Placebo Comparator group

Treatment:

Drug: Placebo for MEDI-578