Back to resultsStudy Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
Primary Purpose
Rotator Cuff Tear
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMP-655/ACS or Standard of Care
BMP-655/ACS or Standard of Care
BMP-655/ACS or Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring rotator cuff tear repair, open surgical technique, safety
Eligibility Criteria
Inclusion Criteria:
- Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.
Exclusion Criteria:
- Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
- Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
- Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
- Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
- Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
- Subjects who are either unwilling or unable to undergo examination with closed MRI.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Arm A
Arm B
Arm C
Outcomes
Primary Outcome Measures
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests
Secondary Outcome Measures
Investigator Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00936559
Brief Title
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
Official Title
Randomized, Single-Blind, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
Detailed Description
This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions.
Patients already enrolled in the study, should continue to complete assessments as described in the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
rotator cuff tear repair, open surgical technique, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Arm A
Arm Title
2
Arm Type
Experimental
Arm Description
Arm B
Arm Title
3
Arm Type
Experimental
Arm Description
Arm C
Intervention Type
Biological
Intervention Name(s)
BMP-655/ACS or Standard of Care
Intervention Description
Decision was made by Legal to withhold this information
Intervention Type
Biological
Intervention Name(s)
BMP-655/ACS or Standard of Care
Intervention Description
Decision was made by Legal to withhold this information.
Intervention Type
Biological
Intervention Name(s)
BMP-655/ACS or Standard of Care
Intervention Description
Decision was made by Legal to withhold this information,
Primary Outcome Measure Information:
Title
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Investigator Questionnaire
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.
Exclusion Criteria:
Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
Subjects who are either unwilling or unable to undergo examination with closed MRI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Pfizer Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
28932752
Citation
Ide J, Mochizuki Y, van Noort A, Ochi H, Sridharan S, Itoi E, Greiner S. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair-A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2-A Pilot Study of Functional Recovery and Structural Outcomes. Orthop J Sports Med. 2017 Sep 12;5(9):2325967117726740. doi: 10.1177/2325967117726740. eCollection 2017 Sep.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3202V1-1001&StudyName=Study%20Evaluating%20Safety%20Of%20BMP-655/ACS%20As%20An%20Adjuvant%20Therapy%20For%20Rotator%20Cuff%20Repair
Description
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Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
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