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NCT00231478 · ClinicalTrials.gov registry record · Phase 4
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 171
- Enrollment target
NCT00231478: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00231478 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 171 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00231478, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 171 participants
- Enrollment target
Study Summary
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.
Primary Outcome
Number of patients with no vomiting is described as no emesis up to 2 hours after surgery
Interventions
- DRUG granisetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2007-04 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
What the finished NCT00231478 record still lists
NCT00231478 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which granisetron is the first listed.
NCT00231478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00231478 about?
NCT00231478 is a clinical study titled "A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy". This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes pr...
What is the current status of trial NCT00231478?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 171 participants. The study started on 2007-04. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00231478?
The interventions under investigation include: granisetron (DRUG).
Who is sponsoring clinical trial NCT00231478?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00231478's enrollment target sits among peer trials
171 484th of 2000 higher than 1,517 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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