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:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01001715
First received: October 26, 2009
Last updated: October 23, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Back Pain |
Drug: REGN475/SAR164877 Drug: Placebo (for REGN475/SAR164877) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 41 |
| Study Start Date: | November 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: REGN475/SAR164877
REGN475/SAR164877, single injection, dose depending on the participant's body weight
|
Drug: REGN475/SAR164877
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
|
Placebo Comparator: Placebo
Placebo (for REGN475/SAR164877), single injection
|
Drug: Placebo (for REGN475/SAR164877)
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001715
Locations
| United States, California | |
| Sanofi-Aventis Investigational Site Number 840005 | |
| Beverly Hills, California, United States, 90211 | |
| Sanofi-Aventis Investigational Site Number 840001 | |
| Fresno, California, United States, 93710 | |
| Sanofi-Aventis Investigational Site Number 840017 | |
| Sacramento, California, United States, 95817 | |
| Sanofi-Aventis Investigational Site Number 840028 | |
| San Diego, California, United States, 92103 | |
| Sanofi-Aventis Investigational Site Number 840008 | |
| Stockton, California, United States, 95204 | |
| United States, Florida | |
| Sanofi-Aventis Investigational Site Number 840013 | |
| Boynton Beach, Florida, United States, 33472 | |
| Sanofi-Aventis Investigational Site Number 840047 | |
| Clearwater, Florida, United States, 33755 | |
| United States, Georgia | |
| Sanofi-Aventis Investigational Site Number 840034 | |
| Atlanta, Georgia, United States, 30328 | |
| United States, New York | |
| Sanofi-Aventis Investigational Site Number 840026 | |
| New York, New York, United States, 11201 | |
| United States, Texas | |
| Sanofi-Aventis Investigational Site Number 840044 | |
| Fort Worth, Texas, United States, 76117 | |
| Sanofi-Aventis Investigational Site Number 840023 | |
| Southlake, Texas, United States, 76092 | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01001715 History of Changes |
| Other Study ID Numbers: | ACT11308 |
| Study First Received: | October 26, 2009 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Back Pain Spinal Fractures Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Injuries Back Injuries Wounds and Injuries Fractures, Bone |
ClinicalTrials.gov processed this record on May 19, 2013