Intravenous fosaprepitant for the prevention of chemotherapy-induced vomiting in children: A double-blind, placebo-controlled, phase III randomized trial

2018 ◽  
Vol 66 (3) ◽  
pp. e27551 ◽  
Author(s):  
Venkatraman Radhakrishnan ◽  
Archit Joshi ◽  
Jaikumar Ramamoorthy ◽  
Swaminathan Rajaraman ◽  
Prasanth Ganesan ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Phase Iii ◽  
Double Blind ◽  
Double Blind Placebo

Intravenous fosaprepitant for the prevention of chemotherapy induced vomiting in children: A double blind placebo controlled, phase III randomized trial.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 10527-10527
Author(s):  
Archit Joshi ◽  
Venkatraman Radhakrishnan ◽  
Jaikumar Ramamoorthy ◽  
Trivadi S. Ganesan ◽  
Swaminathan Rajaraman ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Phase Iii ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes, N07C1

2010 ◽  
Vol 28 (4) ◽  
pp. 641-647 ◽  
Author(s):  
Charles L. Loprinzi ◽  
Rui Qin ◽  
Ernie P. Baclueva ◽  
Kathleen A. Flynn ◽  
Kendrith M. Rowland ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Trial Design ◽  
Hot Flashes ◽  
Phase Iii ◽  
Target Dose ◽  
Double Blind ◽  
Hot Flash ◽  
Double Blind Placebo ◽  
Current Trial ◽  
Controlled Evaluation

Purpose Hot flashes are a common problem for which effective and safe treatments are needed. The current trial was conducted on the basis of preliminary promising data that pregabalin decreased hot flashes. Patients and Methods A double-blind, placebo-controlled, randomized trial design was used to compare pregabalin at target doses of 75 mg twice daily and 150 mg twice daily with a placebo. Hot flash frequencies and scores (frequency times mean severity) were recorded daily during a baseline week and for six treatment weeks. The primary end point for this study was the change-from-baseline hot flash score during treatment week 6 between the 150 mg twice daily target pregabalin treatment and placebo. Nonparametric Wilcoxon rank sum tests, two-sample t tests, and χ2 tests were used to compare the primary and secondary hot flash efficacy end points between pregabalin treatments and placebo. Results Hot flash score changes available for 163 patients during the sixth treatment week compared with a baseline week decreased by 50%, 65%, and 71% in the placebo, and target 75 mg twice daily and 150 mg twice daily pregabalin arms, respectively (P = .009 and P = .007, comparing respective pregabalin arms to the placebo arm). While some toxicities were significantly more common in the pregabalin arms, being more evident with the higher dose, pregabalin was generally well tolerated by most patients. Conclusion Pregabalin decreases hot flashes and is reasonably well tolerated. A target dose of 75 mg twice daily is recommended. Its effects appear to be roughly comparable to what has been reported with gabapentin and with some newer antidepressants.

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