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

NCT ID: NCT00991172

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sciatica

Keywords

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sciatica sciatic pain pain back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo injection

Group Type PLACEBO_COMPARATOR

Placebo Injection

Intervention Type DRUG

Placebo Subcutaneous injection

active

subcutaneous injection of REGN475

Group Type EXPERIMENTAL

REGN475

Intervention Type DRUG

Single Subcutaneous injection dose level 1

active 2

subcutaneous injection of REGN475

Group Type EXPERIMENTAL

REGN475

Intervention Type DRUG

Single subcutaneous injection dose level 2

Interventions

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REGN475

Single Subcutaneous injection dose level 1

Intervention Type DRUG

REGN475

Single subcutaneous injection dose level 2

Intervention Type DRUG

Placebo Injection

Placebo Subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Tiseo, PhD

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Investigational Site

Birmingham, Alabama, United States

Site Status

Regeneron Investigational Site

Mobile, Alabama, United States

Site Status

Regeneron Investigational Site

Peoria, Arizona, United States

Site Status

Regeneron Investigational Site

Anaheim, California, United States

Site Status

Regeneron Investigational Site

Beverly Hills, California, United States

Site Status

Regeneron Investigational Site

National City, California, United States

Site Status

Regeneron Investigational Site

Santa Ana, California, United States

Site Status

Regeneron Investigational Site

Milford, Connecticut, United States

Site Status

Regeneron Investigational Site

Stamford, Connecticut, United States

Site Status

Regeneron Investigational Site

Clearwater, Florida, United States

Site Status

Regeneron Investigational Site

Hallandale, Florida, United States

Site Status

Regeneron Investigational Site

St. Petersburg, Florida, United States

Site Status

Regeneron Investigational Site

Tampa, Florida, United States

Site Status

Regeneron Investigational Site

West Palm Beach, Florida, United States

Site Status

Regeneron Investigational Site

Atlanta, Georgia, United States

Site Status

Regeneron Investigational Site

Sandy Springs, Georgia, United States

Site Status

Regeneron Investigational Site

Overland Park, Kansas, United States

Site Status

Regeneron Investigational Site

Rockville, Maryland, United States

Site Status

Regeneron Investigational Site

Kansas City, Missouri, United States

Site Status

Regeneron Investigational Site

Albuquerque, New Mexico, United States

Site Status

Regeneron Investigational Site

Raleigh, North Carolina, United States

Site Status

Regeneron Investigational Site

Cincinnati, Ohio, United States

Site Status

Regeneron Investigational Site

Duncansville, Pennsylvania, United States

Site Status

Regeneron Investigational Site

Tyrone, Pennsylvania, United States

Site Status

Regeneron Investigational Site

Warwick, Rhode Island, United States

Site Status

Regeneron Investigational Site

Greer, South Carolina, United States

Site Status

Regeneron Investigational Site

Memphis, Tennessee, United States

Site Status

Regeneron Investigational Site

El Paso, Texas, United States

Site Status

Regeneron Investigational Site

San Antonio, Texas, United States

Site Status

Regeneron Invesitgational Site

West Jordan, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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R475-PN-0908

Identifier Type: -

Identifier Source: org_study_id