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A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Chikushino, Fukuoka, Japan
Contact
1-800-718-1021
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.
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- Japanese male subjects and surgically sterile or postmenopausal Japanese female
subjects between the ages of 25 and 75 years.

- without tears of the subscapularis or labral pathology requiring surgical repair, as
estimated on closed magnetic resonance imaging (MRI) within 3 months before surgery.

- In the shoulder under study, subjects should be able to achieve a passive range of
motion (ROM), which is at least 150 degrees in forward elevation (flexion), abduction,
and elevation in the scapular plane (scapular abduction). Subjects should have at
least 40 degrees of passive ROM in external rotation. In the contralateral shoulder,
subjects should be able to achieve active ROM, which is at least 150 degrees in
forward elevation (flexion), abduction, and elevation in the scapular plane (scapular
abduction). Subjects should have at least 40 degrees of active ROM in external
rotation.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects who have had previous surgical intervention to the shoulder joint under study
(eg, shoulder arthroscopy, acromioplasty, previous RCR, fracture). Subjects with stage
3 or 4 fatty infiltration (according to the Goutallier grading scale) of their RC
muscles on MRI taken within 3 months prior to surgical repair or subjects with
moderate or severe degenerative glenohumeral arthritis (according to the Samilson and
Prieto arthrosis grading scale ), avascular necrosis, calcific tendonitis,
chondrocalcinosis, hypertrophic osteoarthropathy, or Paget disease of the shoulder
under study or any bone abnormalities (eg, HO, previous fracture) as confirmed on a
radiograph within 3 months prior to surgical repair.

- Subjects with rheumatologic conditions (eg, rheumatoid arthritis, ankylosing
spondylitis) affecting the shoulder joints, or autoimmune disorders. Subjects treated
with more than 3 corticosteroid injections in the shoulder under study within 1 year
prior to planned surgery or subjects treated with any corticosteroid injection in the
shoulder under study within 3 months prior to planned surgery or subjects currently
receiving oral corticosteroids or taking them within the past 3 months.

- Subjects who are either unwilling or unable (eg, because of claustrophobia or the
presence of an automatic cardioverter defibrillator) to undergo examination with
closed MRI. Subjects with any other major illness/condition that will substantially
increase the risk associated with the subject's participation in and completion of the
study.

NCT01122498
Pfizer
Terminated
A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears

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