Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Back Pain

In brief

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 REGN475/SAR164877 in patients with vertebral fracture pain; * to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.

Key facts

Study ID

NCT01001715

Run by

Regeneron Pharmaceuticals

People needed

41

Starts

2009-11-01

Expected to finish

2011-01-01

Last updated by the study team

2013-05-27

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Investigational Site Number 840005 — Beverly Hills, California, United States
• Sanofi-Aventis Investigational Site Number 840001 — Fresno, California, United States
• Sanofi-Aventis Investigational Site Number 840017 — Sacramento, California, United States
• Sanofi-Aventis Investigational Site Number 840028 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840008 — Stockton, California, United States
• Sanofi-Aventis Investigational Site Number 840013 — Boynton Beach, Florida, United States
• Sanofi-Aventis Investigational Site Number 840047 — Clearwater, Florida, United States
• Sanofi-Aventis Investigational Site Number 840034 — Atlanta, Georgia, United States
• Sanofi-Aventis Investigational Site Number 840026 — New York, New York, United States
• Sanofi-Aventis Investigational Site Number 840044 — Fort Worth, Texas, United States
• Sanofi-Aventis Investigational Site Number 840023 — Southlake, Texas, United States

Full record on ClinicalTrials.gov

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