A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
NCT ID: NCT01181232
Last Updated: 2014-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2009-10-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MR low-dose group
Zolpidem MR
oral
MR high-dose group
Zolpidem MR
oral
IR group
Zolpidem IR
oral
Interventions
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Zolpidem MR
oral
Zolpidem IR
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent has been obtained
Exclusion Criteria
* 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 have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
* 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
18 Years
64 Years
ALL
No
Sponsors
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Astellas Pharma Taiwan, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Tainan City, , Taiwan
Taipei, , Taiwan
Countries
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Other Identifiers
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STCR-0901-TW
Identifier Type: -
Identifier Source: org_study_id
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