Back to resultsA Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
Primary Purpose
Sleep Initiation and Maintenance Disorders, Primary Insomnia
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Zolpidem MR
Estazolam
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Insomnia, Zolpidem, Estazolam
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Zolpidem group
Estazolam group
Arm Description
Outcomes
Primary Outcome Measures
Total score of Pittsburgh Sleep Quality Index (PSQ)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956319
Brief Title
A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Primary Insomnia
Keywords
Insomnia, Zolpidem, Estazolam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zolpidem group
Arm Type
Experimental
Arm Title
Estazolam group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zolpidem MR
Other Intervention Name(s)
Stilnox CR, Ambient CR
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Estazolam
Other Intervention Name(s)
Eurodin
Intervention Description
oral
Primary Outcome Measure Information:
Title
Total score of Pittsburgh Sleep Quality Index (PSQ)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Physician's clinical global impression (CGI)
Time Frame
3 weeks
Title
Patient's global impression (PG)
Time Frame
3 weeks
Title
Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary
Time Frame
3 weeks
Title
Incidence and severity of adverse events, including abnormal sleep behavior
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
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