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

This study has been terminated.
(Business decision due to low subject recruitment and enrollment)
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01001715
First received: October 26, 2009
Last updated: May 20, 2013
Last verified: May 2013
History of Changes

October 26, 2009
May 20, 2013
November 2009
January 2011   (final data collection date for primary outcome measure)
Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale [PI-NRS] [ Time Frame: baseline and 4 weeks after injection ] [ Designated as safety issue: No ]

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.
Mean change in pain intensity from baseline to week 4 assessed by daily Pain Intensity Numeric Rating Scale (PI-NRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01001715 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of pain-free days (score "0" pain on PI-NRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of days with rescue analgesia use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO] score [ Time Frame: baseline and 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score [ Time Frame: baseline and 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [PGIC] score [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity [ Time Frame: up to 12 weeks after injection ] [ Designated as safety issue: No ]
  • Pharmacokinetic: REGN475/SAR164877 serum concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mean change in pain intensity from baseline to each week assessed by daily PI-NRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of pain free days (PI-NRS=0) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of days of rescue analgesia use by week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Short Form-12 Item Quality of Life Questionnaire (SF-12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain
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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Back Pain
  • Drug: REGN475/SAR164877

    Pharmaceutical form: solution

    Route of administration: intravenous infusion over 30 minutes

  • Drug: Placebo (for REGN475/SAR164877)

    Pharmaceutical form: solution

    Route of administration: intravenous infusion over 30 minutes
  • Experimental: REGN475/SAR164877
    REGN475/SAR164877, single injection, dose depending on the participant's body weight
    Intervention: Drug: REGN475/SAR164877
  • Placebo Comparator: Placebo
    Placebo (for REGN475/SAR164877), single injection
    Intervention: Drug: Placebo (for REGN475/SAR164877)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01001715
ACT11308
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Regeneron Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP