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

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • Florida Medical Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Biotech

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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