A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Primary Insomnia
Intervention: Zolpidem MR (Drug); Estazolam (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
Overall contact:
Clinical Development Administration Department, Email: clinicaltrials_info@jp.astellas.com
Summary
The purpose of the study is to investigate the efficacy and safety of zolpidem modified
release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary
insomnia.
Clinical Details
Official title: A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients With Primary Insomnia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Total score of Pittsburgh Sleep Quality Index (PSQ)
Secondary outcome: Physician's clinical global impression (CGI)Patient's global impression (PG) Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary Incidence and severity of adverse events, including abnormal sleep behavior
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of primary insomnia based on DSM-IV criteria (307. 42)
- Written informed consent has been obtained
Exclusion Criteria:
- Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg
movement or restless leg syndrome
- Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
- Patients who are known to be current drug or alcohol abuser or likely to
concomitantly consume alcoholic beverages (more than 3 times/week)
- Patients who are pregnant, lactating or intend to become pregnant during the study
period
- Patients who have received antidepressants or anxiolytics will not allow to change
the dose or discontinue the previous medication throughout the study
- Any clinically significant condition, which in the opinion of the investigator makes
the patients unsuitable for the trial
- Participation in any clinical trial within 1 month prior to randomization
Locations and Contacts
Clinical Development Administration Department, Email: clinicaltrials_info@jp.astellas.com
Taipei 100, Taiwan; Recruiting
Additional Information
Starting date: May 2009
Last updated: April 8, 2010
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