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

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00936559
• Other study ID #: 3202V1-1001
• Status: Terminated
• Phase: Phase 1
• First received: July 2, 2009
• Last updated: April 12, 2012
• Start date: September 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Biological:
• BMP-655/ACS or Standard of Care
Decision was made by Legal to withhold this information
• BMP-655/ACS or Standard of Care
Decision was made by Legal to withhold this information.
• BMP-655/ACS or Standard of Care
Decision was made by Legal to withhold this information,

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Hamburg
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Hoofddorp

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests		1 year	Yes
Secondary	Investigator Questionnaire		1 year	No

External Links

•   To obtain contact information for a study center near you, click here.