NCT01001715

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

October 26, 2009

Last Update Submit

May 20, 2013

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Mean change from baseline in pain intensity as assessed by PI-NRS

    baseline and every other weeks up to 12 weeks after injection

  • Percentage of pain-free days (score "0" pain on PI-NRS)

    12 weeks

  • Percentage of days with rescue analgesia use

    12 weeks

  • Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score

    baseline and 4, 8, 12 weeks

  • Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score

    baseline and 4, 8, 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

REGN475/SAR164877

EXPERIMENTAL

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

Drug: REGN475/SAR164877

Placebo

PLACEBO COMPARATOR

Placebo (for REGN475/SAR164877), single injection

Drug: Placebo (for REGN475/SAR164877)

Interventions

REGN475/SAR164877DRUG

Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

REGN475/SAR164877
Placebo (for REGN475/SAR164877)DRUG

Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Sanofi-Aventis Investigational Site Number 840005

Beverly Hills, California, 90211, United States

Location

Sanofi-Aventis Investigational Site Number 840001

Fresno, California, 93710, United States

Location

Sanofi-Aventis Investigational Site Number 840017

Sacramento, California, 95817, United States

Location

Sanofi-Aventis Investigational Site Number 840028

San Diego, California, 92103, United States

Location

Sanofi-Aventis Investigational Site Number 840008

Stockton, California, 95204, United States

Location

Sanofi-Aventis Investigational Site Number 840013

Boynton Beach, Florida, 33472, United States

Location

Sanofi-Aventis Investigational Site Number 840047

Clearwater, Florida, 33755, United States

Location

Sanofi-Aventis Investigational Site Number 840034

Atlanta, Georgia, 30328, United States

Location

Sanofi-Aventis Investigational Site Number 840026

New York, New York, 11201, United States

Location

Sanofi-Aventis Investigational Site Number 840044

Fort Worth, Texas, 76117, United States

Location

Sanofi-Aventis Investigational Site Number 840023

Southlake, Texas, 76092, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

fasinumab

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 27, 2013

Record last verified: 2013-05

Locations

US(11)