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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01181232
Other study ID # STCR-0901-TW
Secondary ID
Status Completed
Phase Phase 4
First received August 4, 2010
Last updated September 9, 2014
Start date October 2009
Est. completion date April 2011

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Zolpidem MR
oral
Zolpidem IR
oral

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

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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