Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
NCT00936559
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- 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.
- 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.
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 13 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |