Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00936559
First received: July 2, 2009
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).


Condition Intervention Phase
Rotator Cuff Tear
Biological: BMP-655/ACS or Standard of Care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm A
Biological: BMP-655/ACS or Standard of Care
Decision was made by Legal to withhold this information
Experimental: 2
Arm B
Biological: BMP-655/ACS or Standard of Care
Decision was made by Legal to withhold this information.
Experimental: 3
Arm C
Biological: BMP-655/ACS or Standard of Care
Decision was made by Legal to withhold this information,

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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936559

Locations
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Hamburg, Germany, 20246
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands
Pfizer Investigational Site
Hoofddorp, Netherlands, 2134 TM
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00936559     History of Changes
Other Study ID Numbers: 3202V1-1001
Study First Received: July 2, 2009
Last Updated: April 12, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
rotator cuff tear repair
open surgical technique
safety

ClinicalTrials.gov processed this record on October 23, 2014