Efficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tablet in Radiotherapy Treatment.

2.50
Hdl Handle:
http://hdl.handle.net/10541/87911
Title:
Efficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tablet in Radiotherapy Treatment.
Authors:
LeBourgeois, J P; McKenna, C J; Coster, B; Feyer, P; Franzén, L; Goedhals, L; Marzecki, Z; Souhami, L; Stewart, Alan L; Tønnessen, F; Haigh, C; Mitchell, T; Wilkinson, J R; Graham, E
Abstract:
A significant number of patients who are receiving radiotherapy experience the distressing side effects of emesis and nausea. Although prophylactic antiemetics are often given to patients who are receiving single-fraction, high-dose radiotherapy to the abdomen, a survey has revealed that antiemetic prophylaxis is not routinely offered to those receiving fractionated radiotherapy. Hence there is a need for an effective treatment of emesis for use in this group of patients. Ondansetron is an effective and well-tolerated antiemetic, which is used for the prevention of both chemotherapy and radiotherapy-induced emesis and nausea. This agent has been developed as a novel freeze-dried oral formulation. Ondansetron orally disintegrating tablets (ondODT) disperse rapidly when placed on the tongue. As the tablet does not need to be swallowed with water, it is a particularly useful formulation for patients who have difficulty with swallowing or who do not feel able to drink. This study was undertaken to investigate the efficacy of ondODT in the treatment of established emesis and nausea induced by radiotherapy. Two doses of ondODT, 8 mg and 16 mg, were compared with placebo in patients who developed emesis and/or moderate/severe nausea after receiving fractionated radiotherapy to sites located between the thorax and the pelvis. The study showed that ondODT was clinically superior to placebo in treating emesis and nausea successfully over a 12-hour period after taking the medication. There were no statistically significant differences between the two doses of ondODT. In the 2 hours after taking the study medication, patients who received ondODT (8 mg and 16 mg) had significantly fewer emetic episodes compared with those who received placebo. They also experienced significantly less nausea. In conclusion, ondODT 8 mg is effective in the treatment of radiotherapy-induced emesis and nausea and provides an effective alternative to the conventional ondansetron tablet.
Affiliation:
Hospital Henri Mondor, Creteil, France.
Citation:
Efficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tablet in Radiotherapy Treatment. 1999, 11 (5):340-7 Clin Oncol (R Coll Radiol)
Journal:
Clinical Oncology
Issue Date:
1999
URI:
http://hdl.handle.net/10541/87911
DOI:
10.1053/clon.1999.9077
PubMed ID:
10591823
Type:
Article
Language:
en
ISSN:
0936-6555
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorLeBourgeois, J Pen
dc.contributor.authorMcKenna, C Jen
dc.contributor.authorCoster, Ben
dc.contributor.authorFeyer, Pen
dc.contributor.authorFranzén, Len
dc.contributor.authorGoedhals, Len
dc.contributor.authorMarzecki, Zen
dc.contributor.authorSouhami, Len
dc.contributor.authorStewart, Alan Len
dc.contributor.authorTønnessen, Fen
dc.contributor.authorHaigh, Cen
dc.contributor.authorMitchell, Ten
dc.contributor.authorWilkinson, J Ren
dc.contributor.authorGraham, Een
dc.date.accessioned2009-12-14T15:58:59Z-
dc.date.available2009-12-14T15:58:59Z-
dc.date.issued1999-
dc.identifier.citationEfficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tablet in Radiotherapy Treatment. 1999, 11 (5):340-7 Clin Oncol (R Coll Radiol)en
dc.identifier.issn0936-6555-
dc.identifier.pmid10591823-
dc.identifier.doi10.1053/clon.1999.9077-
dc.identifier.urihttp://hdl.handle.net/10541/87911-
dc.description.abstractA significant number of patients who are receiving radiotherapy experience the distressing side effects of emesis and nausea. Although prophylactic antiemetics are often given to patients who are receiving single-fraction, high-dose radiotherapy to the abdomen, a survey has revealed that antiemetic prophylaxis is not routinely offered to those receiving fractionated radiotherapy. Hence there is a need for an effective treatment of emesis for use in this group of patients. Ondansetron is an effective and well-tolerated antiemetic, which is used for the prevention of both chemotherapy and radiotherapy-induced emesis and nausea. This agent has been developed as a novel freeze-dried oral formulation. Ondansetron orally disintegrating tablets (ondODT) disperse rapidly when placed on the tongue. As the tablet does not need to be swallowed with water, it is a particularly useful formulation for patients who have difficulty with swallowing or who do not feel able to drink. This study was undertaken to investigate the efficacy of ondODT in the treatment of established emesis and nausea induced by radiotherapy. Two doses of ondODT, 8 mg and 16 mg, were compared with placebo in patients who developed emesis and/or moderate/severe nausea after receiving fractionated radiotherapy to sites located between the thorax and the pelvis. The study showed that ondODT was clinically superior to placebo in treating emesis and nausea successfully over a 12-hour period after taking the medication. There were no statistically significant differences between the two doses of ondODT. In the 2 hours after taking the study medication, patients who received ondODT (8 mg and 16 mg) had significantly fewer emetic episodes compared with those who received placebo. They also experienced significantly less nausea. In conclusion, ondODT 8 mg is effective in the treatment of radiotherapy-induced emesis and nausea and provides an effective alternative to the conventional ondansetron tablet.en
dc.language.isoenen
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAntiemetics-
dc.subject.meshDose Fractionation-
dc.subject.meshDouble-Blind Method-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNausea-
dc.subject.meshOndansetron-
dc.subject.meshRadiotherapy-
dc.subject.meshSerotonin Antagonists-
dc.subject.meshTablets-
dc.subject.meshVomiting-
dc.titleEfficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tablet in Radiotherapy Treatment.en
dc.typeArticleen
dc.contributor.departmentHospital Henri Mondor, Creteil, France.en
dc.identifier.journalClinical Oncologyen

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