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

Phase 2TerminatedNCT01001715

Regeneron Pharmaceuticals41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Back Pain

Interventions

REGN475/SAR164877DRUG

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

Placebo (for REGN475/SAR164877)DRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (11)

Sanofi-Aventis Investigational Site Number 840005

Beverly Hills, California, United States

Sanofi-Aventis Investigational Site Number 840001

Fresno, California, United States

Sanofi-Aventis Investigational Site Number 840017

Sacramento, California, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and 4 weeks after injection

Secondary Outcomes

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

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

Time frame: 12 weeks

Percentage of days with rescue analgesia use

Time frame: 12 weeks

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

Time frame: baseline and 4, 8, 12 weeks

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

Time frame: baseline and 4, 8, 12 weeks

Patient Global Impression of Change [PGIC] score

Time frame: 4, 8, 12 weeks

Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity

Time frame: up to 12 weeks after injection

Pharmacokinetic: REGN475/SAR164877 serum concentration

Time frame: 12 weeks

Data from ClinicalTrials.gov

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