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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 May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Berlin, , 10117 Germany
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
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 to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).

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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Rotator Cuff Tear
  • 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,
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
February 2012
February 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
25 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
Sweden
 
NCT00936559
3202V1-1001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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