NCT00991172

A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Sciatic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.

Conditions

• Sciatica

Interventions

Type	Name	Description
DRUG	REGN475	Single Subcutaneous injection dose level 1
DRUG	REGN475	Single subcutaneous injection dose level 2
DRUG	Placebo Injection	Placebo Subcutaneous injection

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-10-07
• Last updated: 2011-12-08

Locations

30 sites across 1 country: United States