A case study comparing a randomized withdrawal trial and a double-blind long-term trial for assessing the long-term efficacy of an antidepressant

2007 ◽  
Vol 6 (1) ◽  
pp. 9-22 ◽  
Author(s):  
Craig Mallinckrodt ◽  
Christy Chuang-Stein ◽  
Paul McSorley ◽  
Jeffrey Schwartz ◽  
Donald G. Archibald ◽  
...  
Keyword(s):  
Double Blind ◽  
Term Efficacy ◽  
Term Trial

Long-term efficacy of aripiprazole to treat psychosis in schizophrenia: Sub-analysis of two double-blind, haloperidol controlled studies

2007 ◽  
Vol 22 ◽  
pp. S157
Author(s):  
S. Kasper ◽  
R.D. McQuade ◽  
W.H. Carson ◽  
R.N. Marcus
Keyword(s):  
Double Blind ◽  
Term Efficacy

Long-term efficacy and safety of zolpidem extended-release 12.5 mg, in old patients with chronic primary insomnia: a randomized, double-blind, placebo-controlled, parallel-group, multicenter study

2011 ◽  
Vol 26 (S2) ◽  
pp. 1567-1567
Author(s):  
J. Zarra ◽  
L. Schmidt
Keyword(s):  
Extended Release ◽  
Sleep Onset ◽  
Primary Insomnia ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Old Patients ◽  
Double Blind Placebo ◽  
Term Efficacy ◽  
Parallel Group

ObjectiveTo evaluate long-term efficacy and safety of zolpidem extended-release, in old patients for chronic primary insomnia.DesignMulticenter, randomized, double-blind, placebo-controlled, parallel-group.MethodPopulation: Outpatient with aged more of 65 years. Diagnosis: DSM-IV criteria for chronic primary insomnia; Treatment: Single-dose zolpidem extended-release 12.5 mg (n = 128) or placebo (n = 127), self-administered every night.ResultsPatient's Global Impression (PGI) and Clinical Global Impression-Improvement (CGI-I) were assessed every 4 weeks up to six month. Patient Morning Questionnaire (PMQ), recorded daily, assessed subjective sleep measures-sleep onset latency (SOL), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and quality of sleep (QOS)-and next-day functioning. Zolpidem extended-release also was statistically significantly superior to placebo at every time point for PGI (Items 1–4) and CGI-I (P < 0.0001, rank score), TST, WASO, QOS (P < 0.0001), and SOL (P < or = 0.0014); NAW (Months 2–6; P < 0.0001). Sustained improvement (P < 0.0001, all time points) was observed in morning sleepiness and ability to concentrate (P = 0.0014, month 6) with zolpidem extended-release compared with placebo. Most frequent adverse events for zolpidem extended-release were headache, anxiety and somnolence to the morning. No rebound effect was observed during the first 3 nights of discontinuation.ConclusionsThese findings establish the efficacy of dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness.

scholarly journals Long-term efficacy and safety of CT-P10 or rituximab in untreated advanced follicular lymphoma: a randomized phase 3 study

2021 ◽  
Vol 5 (17) ◽  
pp. 3354-3361
Author(s):  
Christian Buske ◽  
Wojciech Jurczak ◽  
Juan-Manuel Sancho ◽  
Edvard Zhavrid ◽  
Jin Seok Kim ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Induction Period ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Advanced Stage ◽  
Phase 3 ◽  
Double Blind ◽  
End Points ◽  
Term Efficacy

Abstract Rituximab biosimilars are a cornerstone of treatment of advanced-stage follicular lymphoma (FL). This double-blind, parallel-group, phase 3 trial randomized (1:1) adults (≥18 years) with stage III to IV indolent B-cell lymphoma, including grades 1 to 3a FL, to receive CT-P10 or rituximab (375 mg/m2 IV), with cyclophosphamide, vincristine, and prednisone, every 3 weeks for 8 cycles (induction period). Patients achieving complete response (CR), unconfirmed CR, or partial response (PR) received CT-P10 or rituximab maintenance for 2 years (375 mg/m2, every 8 weeks). Primary end points were previously reported, proving noninferiority of efficacy and pharmacokinetic equivalence of CT-P10 to rituximab. Secondary end points included overall response rate (PR+CR) during the induction period per 2007 International Working Group (IWG) criteria, survival analyses, and overall safety. Between 28 July 2014 and 29 December 2015, 140 patients were randomized (70 per group). Median follow-up was 39.9 months (interquartile range, 36.7-43.5). Per 1999 IWG criteria, 4-year Kaplan-Meier estimates (95% confidence interval [CI]) for CT-P10 and rituximab were 61% (47% to 73%) and 55% (36% to 70%) for progression-free survival (hazard ratio, 1.33 [95% CI, 0.67-2.63]; P=.409), respectively, and 88% (77% to 94%) and 93% (83% to 97%) for overall survival (5.29 [0.84-33.53]; P=.077). Overall, 90% (CT-P10) and 86% (rituximab) of patients experienced treatment-emergent adverse events. Long-term safety profiles were similar between groups. Findings confirm favorable outcomes for CT-P10–treated patients with advanced-stage FL and demonstrate comparable long-term efficacy and overall safety between CT-P10 and rituximab. This trial was registered at www.clinicaltrials.gov as #NCT02162771.

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