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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01001715
Other study ID # ACT11308
Secondary ID
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


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
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