Last updated: 11/07/2018 18:30:02
A Phase IV, Multi-Center, Two-Arm, Single-Dose Pharmacokinetic Study of Intravenous ZOFRAN in Pediatric Surgical Patients from 1 Month to 24 Months of Age
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase IV, Multi-Center, Two-Arm, Single-Dose Pharmacokinetic Study of Intravenous ZOFRAN in Pediatric Surgical Patients from 1 Month to 24 Months of Age
Trial description: A Phase IV, Multi-Center, Two-Arm, Single-Dose Pharmacokinetic Study of Intravenous ZOFRAN in Pediatric Surgical Patients from 1 Month to 24 Months of Age
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia. Khalil, S. N., Roth, A. G., Cohen, I. T., Simhi, E., Ansermino, J. M., Bolos, M. E., Cote, C. J., Hannallah, R. S., Davis, P. J., Brooks, P. B., Russo, M. W., Anschuetz, G. C., and Blackburn, L. M. Anesth Analg 2005; 101 (2):356-61, table of contents.
Ondansetron in Prevention of Postoperative Emesis in 1 to 24 Month Old Pediatric Patients, Samia Khalil, M.D., Andrew Roth, M.D., Ira Cohen, M.D., Eli Simhi, M.D., Mark Anser-mino, M.D. 55th Annual Meeting of the American Society of Anesthesiologists. 10/23/2004 Las Vegas, NV; USA
Ondansetron in Prevention of Postoperative Emesis in 1- to 24- Month-Old Pediatric Patients, Khalil, S.N.; Roth, A.; Cohen, I.; Simhi, E.; Ansermino, M. Society for Pediatric Anesthesiology Winter Meeting 2005.2/24/2005 Miami Beach, FL; USA.
Medical condition
Nausea and Vomiting, Postoperative
Product
ondansetron
Collaborators
Not applicable
Study date(s)
January 2002 to Invalid Date
Type
Not applicable
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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