Sleep Initiation and Maintenance Disorders Clinical Trial
Official title:
A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia
Verified date | August 2014 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: National Bureau of Controlled Drugs |
Study type | Interventional |
The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
Status | Completed |
Enrollment | 132 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
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 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc | Astellas Pharma Taiwan, Inc. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rest/activity cycles measured by Actigraphy | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Primary | Total score of Pittsburgh Sleep Quality Index (PSQI) | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Secondary | Physician's clinical global impression (CGI) | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Secondary | Patient's global impression (PGI) | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Secondary | Sleep latency as derived from sleep diary | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Secondary | Number of awakenings as derived from sleep diary | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Secondary | Total sleep time as derived from sleep diary | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Secondary | Wake time after sleep onset as derived from sleep diary | For 2 weeks (Day 0, Day 7, Day 14) | No | |
Secondary | Day time function as assessed by Epworth Sleepiness Scale (ESS) | For 2 weeks (Day 0, Day 7, Day 14) | Yes |
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