Clinical trial NCT00991172: A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sciatica
Keywords: sciatica
sciatic pain
pain
back pain
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-10-07
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sciatic pain between baseline and end of week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Additional measures of sciatic pain.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Regeneron Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Regeneron Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Regeneron Investigational Site
state: California
city: National City
country: United States
facility: Regeneron Investigational Site
state: California
city: Santa Ana
country: United States
facility: Regeneron Investigational Site
state: California
city: Milford
country: United States
facility: Regeneron Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: Regeneron Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: Regeneron Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Regeneron Investigational Site
state: Kansas
city: Rockville
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: Kansas City
country: United States
facility: Regeneron Investigational Site
state: Missouri
city: Albuquerque
country: United States
facility: Regeneron Investigational Site
state: New Mexico
city: Raleigh
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Duncansville
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Tyrone
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Regeneron Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Regeneron Investigational Site
state: Tennessee
city: El Paso
country: United States
facility: Regeneron Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Investigational Site
state: Texas
city: West Jordan
country: United States
facility: Regeneron Invesitgational Site
state: Utah
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Paul Tiseo, PhD
role: STUDY_DIRECTOR
References: