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

Osteoarthritis of the Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133613
• Other study ID #: 09-OA-003
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2010
• Last updated: January 30, 2012
• Start date: May 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Stryker Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Bone morphogenetic protein 7
Single intraarticular injection of BMP-7 or placebo on Day 1

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Florida Medical Research Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Biotech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)		Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24	Yes
Secondary	WOMAC pain and function		Baseline, Week 4, Week 8, Week 12, Week 24	No
Secondary	Patient and physician global VAS		Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24	No
Secondary	Quality of life measurement (SF-36) and pain medication use		Baseline, Week 4, Week 8, Week 12, Week 24	No