Status:
TERMINATED
Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Back Pain
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture. Secondary objectives were: * to assess the safety and tolerability of ...
Detailed Description
The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.
- Exclusion criteria:
- Mild pain score on the Pain Intensity-Numeric Rating Scale \[PI-NRS\] at screening and randomization visits;
- Narcotic addiction;
- Post-fracture vertebral instability;
- Unwillingness to use study-defined rescue analgesia exclusively.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01001715
Start Date
November 1 2009
End Date
January 1 2011
Last Update
May 27 2013
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Investigational Site Number 840005
Beverly Hills, California, United States, 90211
2
Sanofi-Aventis Investigational Site Number 840001
Fresno, California, United States, 93710
3
Sanofi-Aventis Investigational Site Number 840017
Sacramento, California, United States, 95817
4
Sanofi-Aventis Investigational Site Number 840028
San Diego, California, United States, 92103