A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
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
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 9, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 6, 2011
October 1, 2011
1.5 years
August 9, 2009
October 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total score of Pittsburgh Sleep Quality Index (PSQ)
3 weeks
Secondary Outcomes (4)
Physician's clinical global impression (CGI)
3 weeks
Patient's global impression (PG)
3 weeks
Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary
3 weeks
Incidence and severity of adverse events, including abnormal sleep behavior
3 weeks
Study Arms (2)
Zolpidem group
EXPERIMENTALEstazolam group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
- Written informed consent has been obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2009
First Posted
August 11, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
October 6, 2011
Record last verified: 2011-10