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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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 171 participants.
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.
Interventions
- DRUG granisetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2007-04 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00231478
The ClinicalTrials.gov registry entry for NCT00231478 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which granisetron is the first listed.
NCT00231478 reports 0 study locations.
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.
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