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Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

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NCT00936559

Last updated on April 4, 2020
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Study Location
Pfizer Investigational Site
Berlin, , 10117 Germany
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rotator Cuff Tear
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
25-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00936559
Pfizer
Terminated
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

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Descriptive Information
Brief Title  ICMJE Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Tear
Intervention  ICMJE
  • Biological: BMP-655/ACS or Standard of Care
    Decision was made by Legal to withhold this information
  • Biological: BMP-655/ACS or Standard of Care
    Decision was made by Legal to withhold this information.
  • Biological: BMP-655/ACS or Standard of Care
    Decision was made by Legal to withhold this information,
Study Arms  ICMJE
  • Experimental: 1
    Arm A
    Intervention: Biological: BMP-655/ACS or Standard of Care
  • Experimental: 2
    Arm B
    Intervention: Biological: BMP-655/ACS or Standard of Care
  • Experimental: 3
    Arm C
    Intervention: Biological: BMP-655/ACS or Standard of Care
Publications * 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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 12, 2012) 		13
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2009) 		48
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands
Removed Location Countries Sweden
 
Administrative Information
NCT Number  ICMJE NCT00936559
Other Study ID Numbers  ICMJE 3202V1-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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