Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain

This study has been terminated.
(Business decision due to low subject recruitment and enrollment)
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01001715
First received: October 26, 2009
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture.

Secondary objectives were:

  • to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain;
  • to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.

Condition Intervention Phase
Back Pain
Drug: REGN475/SAR164877
Drug: Placebo (for REGN475/SAR164877)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Vertebral Fracture Associated With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS] [ Time Frame: baseline and 4 weeks after injection ] [ Designated as safety issue: No ]

    The baseline value was defined as the average of PI-NRS values obtained at screening and at randomization visit.

    The Week 4 value was defined as the average of PI-NRS values obtained daily through e-Diary assessments during Week 4.



Secondary Outcome Measures:
  • Mean change from baseline in pain intensity as assessed by PI-NRS [ Time Frame: baseline and every other weeks up to 12 weeks after injection ] [ Designated as safety issue: No ]
  • Percentage of pain-free days (score "0" pain on PI-NRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of days with rescue analgesia use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score [ Time Frame: baseline and 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score [ Time Frame: baseline and 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [PGIC] score [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity [ Time Frame: up to 12 weeks after injection ] [ Designated as safety issue: No ]
  • Pharmacokinetic: REGN475/SAR164877 serum concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REGN475/SAR164877
REGN475/SAR164877, single injection, dose depending on the participant's body weight
Drug: REGN475/SAR164877

Pharmaceutical form: solution

Route of administration: intravenous infusion over 30 minutes

Placebo Comparator: Placebo
Placebo (for REGN475/SAR164877), single injection
Drug: Placebo (for REGN475/SAR164877)

Pharmaceutical form: solution

Route of administration: intravenous infusion over 30 minutes


Detailed Description:

The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.

Exclusion criteria:

  • Mild pain score on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;
  • Narcotic addiction;
  • Post-fracture vertebral instability;
  • Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001715

Locations
United States, California
Sanofi-Aventis Investigational Site Number 840005
Beverly Hills, California, United States, 90211
Sanofi-Aventis Investigational Site Number 840001
Fresno, California, United States, 93710
Sanofi-Aventis Investigational Site Number 840017
Sacramento, California, United States, 95817
Sanofi-Aventis Investigational Site Number 840028
San Diego, California, United States, 92103
Sanofi-Aventis Investigational Site Number 840008
Stockton, California, United States, 95204
United States, Florida
Sanofi-Aventis Investigational Site Number 840013
Boynton Beach, Florida, United States, 33472
Sanofi-Aventis Investigational Site Number 840047
Clearwater, Florida, United States, 33755
United States, Georgia
Sanofi-Aventis Investigational Site Number 840034
Atlanta, Georgia, United States, 30328
United States, New York
Sanofi-Aventis Investigational Site Number 840026
New York, New York, United States, 11201
United States, Texas
Sanofi-Aventis Investigational Site Number 840044
Fort Worth, Texas, United States, 76117
Sanofi-Aventis Investigational Site Number 840023
Southlake, Texas, United States, 76092
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01001715     History of Changes
Other Study ID Numbers: ACT11308
Study First Received: October 26, 2009
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Spinal Fractures
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone

ClinicalTrials.gov processed this record on April 15, 2014