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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00991172
First received: September 4, 2009
Last updated: December 1, 2011
Last verified: December 2011
History of Changes

September 4, 2009
December 1, 2011
November 2009
May 2010   (final data collection date for primary outcome measure)
Sciatic pain between baseline and end of week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00991172 on ClinicalTrials.gov Archive Site
Additional measures of sciatic pain. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sciatica
  • Drug: REGN475
    Single Subcutaneous injection dose level 1
  • Drug: REGN475
    Single subcutaneous injection dose level 2
  • Drug: Placebo Injection
    Placebo Subcutaneous injection
  • Placebo Comparator: placebo injection
    Intervention: Drug: Placebo Injection
  • Experimental: active
    subcutaneous injection of REGN475
    Intervention: Drug: REGN475
  • Experimental: active 2
    subcutaneous injection of REGN475
    Intervention: Drug: REGN475
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit.
  2. A confirmed diagnosis of sciatica at the screening visit.
  3. Weight less than 120 kg

Exclusion Criteria:

  1. Back surgery within 6 months prior to the screening visit
  2. Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica
  3. Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc.
  4. Allergy to doxycycline or related compounds
  5. Women who are pregnant or nursing
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00991172
R475-PN-0908
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Paul Tiseo, PhD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP