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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014