NCT00936559

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
BIOLOGICAL	BMP-655/ACS or Standard of Care	Decision was made by Legal to withhold this information
BIOLOGICAL	BMP-655/ACS or Standard of Care	Decision was made by Legal to withhold this information.
BIOLOGICAL	BMP-655/ACS or Standard of Care	Decision was made by Legal to withhold this information,

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-07-10
• Last updated: 2012-04-13

Locations

4 sites across 2 countries: Germany, Netherlands