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

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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 REGN475/SAR164877 in patients with vertebral fracture pain;

• to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Fasinumab

Criteria

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.