search
Back to results

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

Primary Purpose

Back Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
REGN475/SAR164877
Placebo (for REGN475/SAR164877)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Investigational Site Number 840005
  • Sanofi-Aventis Investigational Site Number 840001
  • Sanofi-Aventis Investigational Site Number 840017
  • Sanofi-Aventis Investigational Site Number 840028
  • Sanofi-Aventis Investigational Site Number 840008
  • Sanofi-Aventis Investigational Site Number 840013
  • Sanofi-Aventis Investigational Site Number 840047
  • Sanofi-Aventis Investigational Site Number 840034
  • Sanofi-Aventis Investigational Site Number 840026
  • Sanofi-Aventis Investigational Site Number 840044
  • Sanofi-Aventis Investigational Site Number 840023

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

REGN475/SAR164877

Placebo

Arm Description

REGN475/SAR164877, single injection, dose depending on the participant's body weight

Placebo (for REGN475/SAR164877), single injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean change from baseline in pain intensity as assessed by PI-NRS
Percentage of pain-free days (score "0" pain on PI-NRS)
Percentage of days with rescue analgesia use
Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score
Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score
Patient Global Impression of Change [PGIC] score
Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity
Pharmacokinetic: REGN475/SAR164877 serum concentration

Full Information

First Posted
October 26, 2009
Last Updated
May 20, 2013
Sponsor
Regeneron Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01001715
Brief Title
Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Business decision due to low subject recruitment and enrollment
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REGN475/SAR164877
Arm Type
Experimental
Arm Description
REGN475/SAR164877, single injection, dose depending on the participant's body weight
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for REGN475/SAR164877), single injection
Intervention Type
Drug
Intervention Name(s)
REGN475/SAR164877
Intervention Description
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo (for REGN475/SAR164877)
Intervention Description
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
Primary Outcome Measure Information:
Title
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS]
Description
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.
Time Frame
baseline and 4 weeks after injection
Secondary Outcome Measure Information:
Title
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
Title
Percentage of pain-free days (score "0" pain on PI-NRS)
Time Frame
12 weeks
Title
Percentage of days with rescue analgesia use
Time Frame
12 weeks
Title
Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score
Time Frame
baseline and 4, 8, 12 weeks
Title
Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score
Time Frame
baseline and 4, 8, 12 weeks
Title
Patient Global Impression of Change [PGIC] score
Time Frame
4, 8, 12 weeks
Title
Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity
Time Frame
up to 12 weeks after injection
Title
Pharmacokinetic: REGN475/SAR164877 serum concentration
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Investigational Site Number 840005
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840001
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840017
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840028
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840008
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840013
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840047
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33755
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840034
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840026
City
New York
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840044
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76117
Country
United States
Facility Name
Sanofi-Aventis Investigational Site Number 840023
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs