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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Ondansetron suppository: A randomised, double-blind, double-dummy, parallel-group comparison with oral ondansetron for the prevention of cyclophosphamide induced emesis and nausea
Oncology (Switzerland), Volume 54, No. 5, Year 1997
Notification
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Description
This multinational, multicentre, randomised, parallel-group study compared the safety, tolerability and efficacy of ondansetron 8 mg orally twice a day with ondansetron suppository 16 mg once daily in patients receiving cyclophosphamide-containing chemotherapy. A total of 406 patients were randomised to receive ondansetron 8 mg p.o. (198 patients) or ondansetron suppository (208 patients) medication in a double-blind, double-dummy trial. The primary efficacy analysis revealed that ondansetron provided good anti-emetic control with 81% of patients in the 8 mg p.o. b.d. group and 73% of patients in the 16 mg ondansetron suppository o.d. group experiencing complete or major control of emesis (≤ 2 emetic episodes) on the worst day of days 1-3. The 90% confidence interval for the difference between the two treatments for complete or major control (1.4, 15.0%) showed that the treatments could be regarded as equivalent. A difference in favour of oral ondansetron treatment was noted for the complete control (0 emetic episodes) rates over days 1-3, but no differences were found on day 1. There were no significant differences in the distribution of nausea grades between the treatment groups on the worst day of days 1-3 or on day 1. The incidence of adverse events was similar for the two treatment groups, the most frequently reported events were headache and constipation. There were no significant laboratory findings in either treatment group. In conclusion this study showed that the ondansetron treatments could be regarded as equivalent for the primary efficacy endpoint and that ondansetron suppository was well tolerated and effective in the prevention of cyclo-phosphamide-induced emesis. © 1997 S. Karger AG, Basel.
Authors & Co-Authors
Davidson, Neville G.P.
United Kingdom, London
North Middlesex University Hospital
Paska, W.
United Kingdom, Brentford
Glaxosmithkline Plc.
van Belle, Simon J.P.
Belgium, Ghent
Universitair Ziekenhuis Gent
Goedhals, Louis
South Africa, Bloemfontein
National Hospital Bloemfontein
McQuade, B.
United Kingdom, Brentford
Glaxosmithkline Plc.
McRae, J.
United Kingdom, Brentford
Glaxosmithkline Plc.
Bonaventura, B.
Unknown Affiliation
Boyer, B.
Unknown Affiliation
Olver, O.
Unknown Affiliation
Prosser, P.
Unknown Affiliation
Baumgartner, B.
Unknown Affiliation
Kienzer, K.
Unknown Affiliation
Schuller, S.
Unknown Affiliation
Van Belle, V.
Unknown Affiliation
Warnier, W.
Unknown Affiliation
Bekker, B.
Unknown Affiliation
Mejer, M.
Unknown Affiliation
Philip, P.
Unknown Affiliation
Audhuy, A.
Unknown Affiliation
Corette, C.
Unknown Affiliation
Dalivoust, D.
Unknown Affiliation
Lejcune, L.
Unknown Affiliation
Nouyrigat, N.
Unknown Affiliation
Soubeyran, S.
Unknown Affiliation
Tubiana, T.
Unknown Affiliation
Barten, B.
Unknown Affiliation
Braumann, B.
Unknown Affiliation
Christmann, C.
Unknown Affiliation
Du Bois, D.
Unknown Affiliation
Hurat, H.
Unknown Affiliation
Westerhausen, W.
Unknown Affiliation
Ten Bokkel-Huininek, T.
Unknown Affiliation
Verweij, V.
Unknown Affiliation
Ashkenazi, A.
Unknown Affiliation
Inbar, I.
Unknown Affiliation
Shapira, S.
Unknown Affiliation
Borge, B.
Unknown Affiliation
Brunsvig, B.
Unknown Affiliation
Erikstein, E.
Unknown Affiliation
Kassa, K.
Unknown Affiliation
Kvaloy, K.
Unknown Affiliation
Norunt, N.
Unknown Affiliation
Goedhals, G.
Unknown Affiliation
Johnson, J.
Unknown Affiliation
Agrup, A.
Unknown Affiliation
Albertsson, A.
Unknown Affiliation
Carlsson, C.
Unknown Affiliation
Fomander, F.
Unknown Affiliation
Malmestrom, M.
Unknown Affiliation
Svensson, S.
Unknown Affiliation
Aapro, A.
Unknown Affiliation
Buser, B.
Unknown Affiliation
Obrist, O.
Unknown Affiliation
Sessa, S.
Unknown Affiliation
Cunninham, C.
Unknown Affiliation
Davidson, D.
Unknown Affiliation
Earl, E.
Unknown Affiliation
Stewart, S.
Unknown Affiliation
Statistics
Citations: 58
Authors: 58
Affiliations: 4
Identifiers
Doi:
10.1159/000227723
ISSN:
00302414
e-ISSN:
14230232
Research Areas
Cancer
Disability
Health System And Policy
Study Design
Cohort Study