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NCT01001715 · ClinicalTrials.gov registry record · Phase 2
Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT01001715: Clinical Trial Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT01001715 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01001715, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG REGN475/SAR164877
- DRUG Placebo (for REGN475/SAR164877)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
Why NCT01001715 stopped before completion
NCT01001715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which REGN475/SAR164877 is the first listed.
NCT01001715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01001715 about?
NCT01001715 is a clinical study titled "Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain". 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 an...
What is the current status of trial NCT01001715?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2009-11. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01001715?
The interventions under investigation include: REGN475/SAR164877 (DRUG), Placebo (for REGN475/SAR164877) (DRUG).
Who is sponsoring clinical trial NCT01001715?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01001715's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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