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

Sciatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991172
• Other study ID #: R475-PN-0908
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2009
• Last updated: December 1, 2011
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: December 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sciatica

Intervention

Drug:
• REGN475
Single Subcutaneous injection dose level 1
• REGN475
Single subcutaneous injection dose level 2
• Placebo Injection
Placebo Subcutaneous injection

Locations

Country	Name	City	State
United States	Regeneron Investigational Site	Albuquerque	New Mexico
United States	Regeneron Investigational Site	Anaheim	California
United States	Regeneron Investigational Site	Atlanta	Georgia
United States	Regeneron Investigational Site	Beverly Hills	California
United States	Regeneron Investigational Site	Birmingham	Alabama
United States	Regeneron Investigational Site	Cincinnati	Ohio
United States	Regeneron Investigational Site	Clearwater	Florida
United States	Regeneron Investigational Site	Duncansville	Pennsylvania
United States	Regeneron Investigational Site	El Paso	Texas
United States	Regeneron Investigational Site	Greer	South Carolina
United States	Regeneron Investigational Site	Hallandale Beach	Florida
United States	Regeneron Investigational Site	Kansas City	Missouri
United States	Regeneron Investigational Site	Memphis	Tennessee
United States	Regeneron Investigational Site	Milford	Connecticut
United States	Regeneron Investigational Site	Mobile	Alabama
United States	Regeneron Investigational Site	National City	California
United States	Regeneron Investigational Site	Overland Park	Kansas
United States	Regeneron Investigational Site	Peoria	Arizona
United States	Regeneron Investigational Site	Raleigh	North Carolina
United States	Regeneron Investigational Site	Rockville	Maryland
United States	Regeneron Investigational Site	San Antonio	Texas
United States	Regeneron Investigational Site	Sandy Springs	Georgia
United States	Regeneron Investigational Site	Santa Ana	California
United States	Regeneron Investigational Site	St. Petersburg	Florida
United States	Regeneron Investigational Site	Stamford	Connecticut
United States	Regeneron Investigational Site	Tampa	Florida
United States	Regeneron Investigational Site	Tyrone	Pennsylvania
United States	Regeneron Investigational Site	Warwick	Rhode Island
United States	Regeneron Invesitgational Site	West Jordan	Utah
United States	Regeneron Investigational Site	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sciatic pain between baseline and end of week 4		4 weeks	No
Secondary	Additional measures of sciatic pain.		6 weeks	No