- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111045
Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
January 30, 2012 updated by: Stryker Biotech
A Phase 2, Double Blind, Randomized, Placebo-Controlled, Proof of Concept, Dose Finding Study of Intraarticular Bone Morphogenetic Protein (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
The objectives of the study are to evaluate the safety and efficacy of intraarticular BMP-7 for the treatment of osteoarthritis of the knee.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
355
Phase
- Phase 2
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
-
-
Arizona
-
Glendale, Arizona, United States, 85304
- Arizona Arthritis and Rheumatology Research
-
Tucson, Arizona, United States, 85724
- University of Arizona Arthritis Center
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University School of Medicine
-
Sacramento, California, United States, 95817
- UC Davis Medical Center, Center for Aging
-
Tustin, California, United States, 92780
- Robin Dore, MD, Inc
-
-
Colorado
-
Boulder, Colorado, United States, 80304
- Boulder Medical Center, PC
-
-
Florida
-
Boca Raton, Florida, United States, 33486
- Rheumatology Associates of S. Florida
-
Palm Harbor, Florida, United States, 34684
- The Arthritis Center
-
Stuart, Florida, United States, 34996
- Rheumatology Associates
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Center for Clinical Research
-
Chicago, Illinois, United States, 60616
- Apex Medical Research, AMR, Inc
-
Morton Grove, Illinois, United States, 60053
- Illinois Bone And Joint Institute
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Medical Center
-
Cumberland, Maryland, United States, 21502
- Klein & Associates, MD, PA
-
Frederick, Maryland, United States, 21702
- Arthritis and Osteoporosis Center of Maryland
-
-
Missouri
-
Kansas City, Missouri, United States, 64114
- The Center for Pharmaceutical Research, PC
-
-
Montana
-
Billings, Montana, United States, 59101
- Billings Clinic
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
-
Mayfield Village, Ohio, United States, 44143
- David R. Mandel, MD, Inc.
-
-
Pennsylvania
-
Duncansville, Pennsylvania, United States, 16635
- Altoona Center for Clinical Research
-
West Reading, Pennsylvania, United States, 19611
- Clinical Research Center of Reading
-
-
Texas
-
Dallas, Texas, United States, 75231
- Baylor Research Institute
-
Houston, Texas, United States, 77074
- Houston Institute For Clinical Research
-
Houston, Texas, United States, 77090
- Houston Medical Research Associates
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Tacoma Center for Arthritis Research
-
-
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
38 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. Symptoms must include knee joint pain.
- A male or female adult age >40 years
- female subjects of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test on the day of injection
- Radiographic evidence of at least one tibiofemoral osteophyte and Osteoarthritis Research Society International (OARSI) Atlas joint space narrowing grade of 1 or 2 in the index knee
- WOMAC pain score of >8 at screening and baseline
- Able to comply with the study and give informed consent
- Able to read, write and understand English
Exclusion Criteria:
- A requirement for treatment with opioids for pain relief.
- Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hours and acetaminophen for 24 hours prior to pain assessments during the study. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
- Using a handicap assistance device (i.e., cane, walker) >50% of the time.
- Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening visit 1 and will not remain stable during their participation in the study.
- History of arthroscopic or open surgery to the index knee in the past 12 months or planned surgery during study.
- History of joint replacement surgery (index knee).
- Received corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening and/or not willing to abstain from treatments for the duration of the study
- Received long acting hyaluronic acid injection of the index knee within 6 months of screening and/or not willing to abstain from treatments for the duration of the study.
- History in the past 10 years of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
- Clinical signs and symptoms of active knee infection or radiographic evidence of crystal disease other than chondrocalcinosis (i.e., gout and CPPD).
- A history of abnormal laboratory results ≥2.5 x ULN indicative of any significant medical disease, which in the opinion of the investigator, would preclude the subjects participation in the study
Any of the following abnormal laboratory results during screening:
- ALT and AST ≥2.5x ULN
- Hemoglobin <11.5 g/dL (Female) or <13.2 g/dL (Male)
- WBC <3500 cells/mm3
- Lymphocyte count ≤1000 cells/mm3
- Serum creatinine ≥1.5 x ULN
- Platelet count below the central laboratory lower limit of normal.
- History of malignancy in the past ten years (<10 years), with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
- Significant hip pain, ipsilateral to the index knee that may interfere with assessments of index knee pain
- Skin breakdown at the knee where the injection would take place
- A known or clinically suspected infection with human immunodeficiency virus (HIV), or hepatitis C or B viruses
- Participated within 3 months or will participate concurrently in another investigational drug or vaccine study
- A history of drug or alcohol dependence or abuse in the past 3 years
- Previous treatment with BMP-7 or any bone morphogenetic protein
- A female with reproductive capability who is unwilling to use birth control for the duration of the study and/or intends to conceive within 12 months of dosing.
- Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1
0.03 mg/ml BMP-7, single intraarticular knee injection
|
Comparison of different doses of the drug via single intraarticular knee injection
|
Active Comparator: Arm 2
0.1 mg/ml BMP-7, single intraarticular knee injection
|
Comparison of different doses of the drug via single intraarticular knee injection
|
Active Comparator: Arm 3
0.3 mg/ml BMP-7, single intraarticular knee injection
|
Comparison of different doses of the drug via single intraarticular knee injection
|
Placebo Comparator: Arm 4
1 ml placebo, single intraarticular knee injection (control)
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale.
Time Frame: Baseline, and at 24 weeks
|
Baseline, and at 24 weeks
|
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
April 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
April 23, 2010
First Submitted That Met QC Criteria
April 26, 2010
First Posted (Estimate)
April 27, 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-002
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.
Clinical Trials on Osteoarthritis of the Knee
-
Taiwan Liposome CompanyCompletedOSTEOARTHRITIS OF THE KNEETaiwan, United States
-
University Hospital, GhentCompletedOsteoarthritis of the Knee JointBelgium
-
Bone Therapeutics S.ANordic Bioscience A/SCompletedSymptomatic Osteoarthritis of the KneeDenmark, Belgium, United Kingdom, Czechia, Hong Kong, Moldova, Republic of, Poland
-
Rush University Medical CenterWithdrawnSymptomatic Osteoarthritis of the Knee
-
Region SkaneRecruitingOsteoarthritis of the Knee or HipSweden
-
UMC UtrechtCompletedMedial Compartment Osteoarthritis of the KneeNetherlands
-
Massachusetts General HospitalGöteborg University; Seoul National University Hospital; Ulsan University Hospital and other collaboratorsUnknownOsteoarthritis of the Knee | Traumatic Arthritis of the KneeUnited States
-
Ampio Pharmaceuticals. Inc.TerminatedSevere Osteoarthritis of the KneeUnited States
-
Hospital General de Jerez de la FronteraZiekenhuis Oost-LimburgCompletedPainful Osteoarthritis of the KneeSpain
-
Ampio Pharmaceuticals. Inc.TerminatedSevere Osteoarthritis of the KneeUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States