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

December 1, 2011 updated by: Regeneron Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo injection
Drug: Placebo Injection
Placebo Subcutaneous injection
EXPERIMENTAL: active
subcutaneous injection of REGN475
Drug: REGN475
Single Subcutaneous injection dose level 1
Drug: REGN475
Single subcutaneous injection dose level 2
EXPERIMENTAL: active 2
subcutaneous injection of REGN475
Drug: REGN475
Single Subcutaneous injection dose level 1
Drug: REGN475
Single subcutaneous injection dose level 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sciatic pain between baseline and end of week 4
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional measures of sciatic pain.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

September 4, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (ESTIMATE)

October 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 1, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R475-PN-0908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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