scholarly journals A DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, CLINICAL STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF LOW DOSE DOXEPIN IN COMPARISION WITH ZOPICLONE IN ADULT AND ELDERLY PATIENTS WITH PRIMARY INSOMNIA

2015 ◽  
Vol 4 (91) ◽  
pp. 15603-15608
Author(s):  
Pali Rastogi ◽  
Deepti Rastogi
Keyword(s):  
Clinical Study ◽  
Elderly Patients ◽  
Low Dose ◽  
Primary Insomnia ◽  
Prospective Clinical Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group

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 Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study

2018 ◽  
Vol 3 ◽  
pp. 72-72 ◽  
Author(s):  
Ovidiu Burta ◽  
Claudia Iacobescu ◽  
Radu Bogdan Mateescu ◽  
Tudor Nicolaie ◽  
Nicoleta Tiuca ◽  
...  
Keyword(s):  
Clinical Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group ◽  
Functional Bloating
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