Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Sciatica
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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. Enro...
Eligibility Criteria
Inclusion
- Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit.
- A confirmed diagnosis of sciatica at the screening visit.
- Weight less than 120 kg
Exclusion
- Back surgery within 6 months prior to the screening visit
- Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica
- Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc.
- Allergy to doxycycline or related compounds
- Women who are pregnant or nursing
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00991172
Start Date
November 1 2009
End Date
May 1 2010
Last Update
December 8 2011
Active Locations (30)
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1
Regeneron Investigational Site
Birmingham, Alabama, United States
2
Regeneron Investigational Site
Mobile, Alabama, United States
3
Regeneron Investigational Site
Peoria, Arizona, United States
4
Regeneron Investigational Site
Anaheim, California, United States