scholarly journals Trial design of a phase III, multicentre, randomised, double-blind, placebo-controlled, 48-week study to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease

2016 ◽  
Author(s):  
Richard A Feelders ◽  
Anthony Heaney ◽  
Karen McBride ◽  
Annie Hilliard ◽  
Chuan Tian ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Trial Design ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo

scholarly journals A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC

2020 ◽  
Vol 15 (2) ◽  
pp. 190-202 ◽  
Author(s):  
Pere Gascón ◽  
Rajnish Nagarkar ◽  
Martin Šmakal ◽  
Konstantinos N. Syrigos ◽  
Carlos H. Barrios ◽  
...  
Keyword(s):  
Darbepoetin Alfa ◽  
Advanced Nsclc ◽  
Phase Iii ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo

Phase III, multicentre, double-blind, randomised withdrawal study of osilodrostat (LCI699) in patients with Cushing's disease: a study design

2015 ◽  
Author(s):  
Akira Shimatsu ◽  
Nicholas Sauter ◽  
Roxzana Kelly ◽  
Peter Unge ◽  
Xin Zhi ◽  
...  
Keyword(s):  
Study Design ◽  
Cushing’S Disease ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Double Blind

scholarly journals Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase

2020 ◽  
Vol 8 (9) ◽  
pp. 748-761 ◽  
Author(s):  
Rosario Pivonello ◽  
Maria Fleseriu ◽  
John Newell-Price ◽  
Xavier Bertagna ◽  
James Findling ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Multicentre Phase ◽  
Phase Iii Study ◽  
Withdrawal Phase

scholarly journals OR16-2 Osilodrostat Treatment in Cushing's Disease (CD): Results from a Phase III, Multicenter, Double-Blind, Randomized Withdrawal Study (LINC 3)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Beverly MK Biller ◽  
John Newell-Price ◽  
Maria Fleseriu ◽  
Xavier Bertagna ◽  
James Findling ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Double Blind

scholarly journals Clinical Evaluation of Ramosetron Injections in the Treatment of Cisplatin-Induced Nausea and Vomiting

2002 ◽  
Vol 30 (3) ◽  
pp. 211-219 ◽  
Author(s):  
K Noda ◽  
M Ikeda ◽  
O Yoshida ◽  
S Yano ◽  
T Taguchi ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Clinical Efficacy ◽  
Clinical Evaluation ◽  
Adverse Reactions ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
Efficacy Analysis

A phase III, double-blind, placebo-controlled study was performed to examine the safety and efficacy of ramosetron in cancer patients with cisplatin-induced nausea/vomiting. Patients were divided into two groups: group R received 0.3 mg ramosetron intravenously and group P received placebo. Eighty-eight patients were enrolled, 44 in each group; 84 (43 in group R, 41 in group P) were included in the clinical efficacy analysis and 86 (44 in group R, 42 in group P) in the safety analysis. Ramosetron was significantly more clinically effective than placebo against nausea, vomiting and anorexia; 65.1% of patients in group R experienced no vomiting in the first 6 h of observation compared with 7.3% of those receiving placebo. No serious adverse reactions or significant differences in safety were observed between the groups. Based on these results, ramosetron injection is effective in the treatment of cisplatin-induced nausea/vomiting and its clinical usefulness is demonstrated here.

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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