Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stryker Biotech

Criteria

Inclusion Criteria

• Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.

• >40 years

• Radiographic evidence of at least one osteophyte in either knee at screening

Exclusion Criteria

• Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)

• Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.

• Received arthroscopic or open surgery to the index knee within 6 months of screening

• History of joint replacement surgery (index knee).

• Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening

• Long acting hyaluronic acid injection of the index knee within 6 months of screening

• History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.

• History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.

• Female subject with reproductive capability.