- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01133613
Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
January 30, 2012 updated by: Stryker Biotech
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32607
- Florida Medical Research Institute
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
0.03 mg/ml BMP-7 or placebo via intraarticular knee injection
|
Single intraarticular injection of BMP-7 or placebo on Day 1
|
Experimental: Cohort 2
0.1 mg/ml BMP-7 or placebo via intraarticular knee injection
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Single intraarticular injection of BMP-7 or placebo on Day 1
|
Experimental: Cohort 3
0.3 mg/ml BMP-7 or placebo via intraarticular knee injection
|
Single intraarticular injection of BMP-7 or placebo on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
Time Frame: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
|
Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
WOMAC pain and function
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24
|
Baseline, Week 4, Week 8, Week 12, Week 24
|
Patient and physician global VAS
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
|
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
|
Quality of life measurement (SF-36) and pain medication use
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24
|
Baseline, Week 4, Week 8, Week 12, Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
May 27, 2010
First Submitted That Met QC Criteria
May 28, 2010
First Posted (Estimate)
May 31, 2010
Study Record Updates
Last Update Posted (Estimate)
February 1, 2012
Last Update Submitted That Met QC Criteria
January 30, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-OA-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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