Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01442376 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 502
- Enrollment target
NCT01442376: Completed Phase 3 study, sponsored by Helsinn Healthcare.
NCT01442376 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 502 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01442376, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 502 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.
Primary Outcome
Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy.
Interventions
- DRUG Ondansetron
- DRUG Palonosetron
- DRUG Placebo to Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01442376 record still lists
NCT01442376 is an interventional study that assigns participants to a tested intervention. The registered 502 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 (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Ondansetron is the first listed.
NCT01442376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01442376 about?
NCT01442376 is a clinical study titled "Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients". The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to ...
What is the current status of trial NCT01442376?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2011-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01442376?
The interventions under investigation include: Ondansetron (DRUG), Palonosetron (DRUG), Placebo to Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01442376?
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 NCT01442376's enrollment target sits among peer trials
502 743rd of 2000 higher than 1,258 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05646381 · 502 participants · Phase 2
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
- NCT05897632 · 502 participants · NA
CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
- NCT05143931 · 503 participants · NA
Avoid and Resist Strategies for Weight Management
- NCT04442022 · 501 participants · Phase 2
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia