Status:
TERMINATED
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
Lead Sponsor:
Pfizer
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
25-75 years
Phase:
PHASE1
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00936559
Start Date
September 1 2010
End Date
February 1 2012
Last Update
April 13 2012
Active Locations (4)
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1
Pfizer Investigational Site
Berlin, Germany, 10117
2
Pfizer Investigational Site
Hamburg, Germany, 20246
3
Pfizer Investigational Site
Amsterdam, Netherlands
4
Pfizer Investigational Site
Hoofddorp, Netherlands, 2134 TM