Status:
COMPLETED
A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Sleep Initiation and Maintenance Disorders
Primary Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
- Written informed consent has been obtained
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00956319
Start Date
May 1 2009
End Date
November 1 2010
Last Update
October 6 2011
Active Locations (1)
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1
Taipei, Taiwan, 100