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

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01001715
• Other study ID #: ACT11308
• Status: Terminated
• Phase: Phase 2
• First received: October 26, 2009
• Last updated: May 20, 2013
• Start date: November 2009
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Spinal Fractures

Intervention

Drug:
• REGN475/SAR164877
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
• Placebo (for REGN475/SAR164877)
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

Locations

Country	Name	City	State
United States	Sanofi-Aventis Investigational Site Number 840034	Atlanta	Georgia
United States	Sanofi-Aventis Investigational Site Number 840005	Beverly Hills	California
United States	Sanofi-Aventis Investigational Site Number 840013	Boynton Beach	Florida
United States	Sanofi-Aventis Investigational Site Number 840047	Clearwater	Florida
United States	Sanofi-Aventis Investigational Site Number 840044	Fort Worth	Texas
United States	Sanofi-Aventis Investigational Site Number 840001	Fresno	California
United States	Sanofi-Aventis Investigational Site Number 840026	New York	New York
United States	Sanofi-Aventis Investigational Site Number 840017	Sacramento	California
United States	Sanofi-Aventis Investigational Site Number 840028	San Diego	California
United States	Sanofi-Aventis Investigational Site Number 840023	Southlake	Texas
United States	Sanofi-Aventis Investigational Site Number 840008	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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