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

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ClinicalTrials.gov Identifier: NCT00936559
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : July 10, 2009
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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

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 : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : September 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
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,



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Investigator Questionnaire [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00936559     History of Changes
Other Study ID Numbers: 3202V1-1001
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries