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NCT01463397 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 191
- Enrollment target
NCT01463397: Completed Phase 2 study, sponsored by Sanofi.
NCT01463397 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 191 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01463397, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 191 participants
- Enrollment target
Study Summary
Primary Objective: To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS). Secondary Objectives: * To compare the effects of SAR292833 with placebo on the change of neuropathic pain symptoms versus baseline Neuropathic Pain Symptoms Inventory (NPSI); * To evaluate the effects of SAR292833 in comparison to placebo on the change in pain intensity of mechanical allodynia; * To investigate the safety and tolerability of SAR292833 in comparison to placebo; * To investigate the pharmacokinetics (PK) and the relationships between main efficacy parameters or pharmacodynamic effect (PD) and pharmacokinetics (PK/PD) of SAR292833 in patients with chronic peripheral neuropathic pain.
Primary Outcome
The average daily pain intensity is the mean of the last consecutive 7 days.
Interventions
- DRUG placebo
- DRUG SAR292833
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01463397 record still lists
NCT01463397 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01463397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01463397 about?
NCT01463397 is a clinical study titled "Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain". Primary Objective: To assess the efficacy of SAR292833 versus placebo in reducing pain intensity associated with chronic peripheral neuropathic pain using 11-point numerical rating scale (NRS). Secondary Objectives: * To compare the effects of SAR292833 with placebo on the change of neuropathic p...
What is the current status of trial NCT01463397?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2012-03. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01463397?
The interventions under investigation include: placebo (DRUG), SAR292833 (DRUG).
Who is sponsoring clinical trial NCT01463397?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01463397's enrollment target sits among peer trials
191 353rd of 2000 higher than 1,648 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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