Last updated: 11/07/2018 18:27:30
A Randomized, Double-Blind, Placebo-Controlled Evaluation of Oral Ondansetron Administered Twice Daily in the Prevention of Nausea and Vomiting Associated with Non-Cisplatin Chemotherapy
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 Randomized, Double-Blind, Placebo-Controlled Evaluation of Oral Ondansetron Administered Twice Daily in the Prevention of Nausea and Vomiting Associated with Non-Cisplatin Chemotherapy
Trial description: A Randomized, Double-Blind, Placebo-Controlled Evaluation of Oral Ondansetron Administered Twice Daily in the Prevention of Nausea and Vomiting Associated with Non-Cisplatin Chemotherapy
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:
Ondansetron for nausea and vomiting associated with moderately emetogenic cancer chemotherapy. DiBenedetto, J. Jr, Cubeddu, L. X., Ryan, T., Kish, J. A., Sciortino, D., Beall, C., Eisenberg, P. D., Henderson, C., Griffin, D., and Wentz, A. Clin Ther 95; 17 (6):1091-8.
Twice Daily Oral Ondansetron Effectively Prevents Nausea and Vomiting Associated with Cyclophosphamide Doxorubicin-Based Chemotherapy, DiBenedetto, J, MD; Cubeddu, L, MD; Ryan, T, Md; Kish, J, MD; Sciortino, D, MD; Beall, C, MD. Providence, Rhode Island; Carcas, Venezuela; Alton, Illinois; Harper Hospital, Detroit, Michigan; Fort Wayne Medical Oncology/Hematology Incorporated, Fort Wayne, Indiana; Morgantown, West Virginia; San Antonio, TX; USA. Identification and Management of High Risk Women -- Rhone-Poulenc Rorer; Satellite Symposium to the 18th Annual San Antonio Breast Cancer Symposium. 12/10/1995
Medical condition
Nausea and Vomiting, Chemotherapy-Induced
Product
ondansetron
Collaborators
Not applicable
Study date(s)
October 1991 to May 1993
Type
Not applicable
Phase
3
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
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
1993-01-05
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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