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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Biotech
ClinicalTrials.gov Identifier:
NCT01133613
First received: May 27, 2010
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
 Drug: Bone morphogenetic protein 7
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Stryker Biotech:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • WOMAC pain and function [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Patient and physician global VAS [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Quality of life measurement (SF-36) and pain medication use [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
0.03 mg/ml BMP-7 or placebo via intraarticular knee injection
 Drug: Bone morphogenetic protein 7
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
 Drug: Bone morphogenetic protein 7
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
 Drug: Bone morphogenetic protein 7
Single intraarticular injection of BMP-7 or placebo on Day 1

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133613

Locations
United States, Florida
Florida Medical Research Institute
Gainesville, Florida, United States, 32607
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Stryker Biotech
  More Information

No publications provided

Responsible Party: Stryker Biotech
ClinicalTrials.gov Identifier: NCT01133613     History of Changes
Other Study ID Numbers: 09-OA-003
Study First Received: May 27, 2010
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013