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

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NCT01122498

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Study Location
Pfizer Investigational Site
Chikushino, Fukuoka, , Japan
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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

- 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.
Show details


- 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.

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Rotator Cuff TearStudy Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
NCT00936559
  1. Berlin,
  2. Hamburg,
  3. Amsterdam,
  4. Hoofddorp,
ALL GENDERS
25 Years+
years
MULTIPLE SITES
Rotator Cuff TearA Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears
NCT01122498
  1. Chikushino, Fukuoka
  2. Kure, Hiroshima
  3. Koushi, Kumamoto
  4. Toyonaka, Osaka
  5. Hiroshima,
  6. Kanagawa,
  7. Kumamoto,
  8. Nagano,
ALL GENDERS
25 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears
Official Title  ICMJE A Phase 1, Randomized, Open-Label, 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 Repair
Brief Summary Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be hospitalized and have a single dose of BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are randomized to receive SOC alone will receive no test article. Following surgery, subjects will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits beginning 24 hours after surgery and continuing through 52 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Tear
Intervention  ICMJE
  • Biological: BMP-655/ACS+Standard of care or Standard of care
    BMP-655/ACS 0.015mg/mL
  • Biological: BMP-655/ACS+Standard of care or Standard of care
    BMP-655/ACS 0.05mg/mL
  • Biological: BMP-655/ACS+Standard of care or Standard of care
    BMP-655/ACS 0.15mg/mL or 0.025mg/mL
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: BMP-655/ACS+Standard of care or Standard of care
  • Experimental: 2
    Intervention: Biological: BMP-655/ACS+Standard of care or Standard of care
  • Experimental: 3
    Intervention: Biological: BMP-655/ACS+Standard of care 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 19, 2012)		23
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2010)		42
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

  • 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.
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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01122498
Other Study ID Numbers  ICMJE 3202V1-1003
B1861003
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 CenterPfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP