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NCT01376297 · ClinicalTrials.gov registry record · Phase 3
A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 413
- Enrollment target
NCT01376297: Completed Phase 3 study, sponsored by Helsinn Healthcare.
NCT01376297 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 413 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01376297, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 413 participants
- Enrollment target
Study Summary
NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.
Primary Outcome
This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupita
Interventions
- DRUG Dexamethasone
- DRUG Palonosetron
- DRUG Aprepitant
- DRUG Netupitant and Palonosetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2011-07 |
| Phase | Phase 3 |
What the finished NCT01376297 record still lists
NCT01376297 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT01376297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01376297 about?
NCT01376297 is a clinical study titled "A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting". NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeate...
What is the current status of trial NCT01376297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 413 participants. The study started on 2011-07.
What interventions are being tested in trial NCT01376297?
The interventions under investigation include: Dexamethasone (DRUG), Palonosetron (DRUG), Aprepitant (DRUG), Netupitant and Palonosetron (DRUG).
Who is sponsoring clinical trial NCT01376297?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01376297's enrollment target sits among peer trials
413 905th of 2000 higher than 1,095 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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