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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00956319
Other study ID # STCR-0802-TW
Secondary ID
Status Completed
Phase Phase 4
First received August 9, 2009
Last updated October 5, 2011
Start date May 2009
Est. completion date November 2010

Study information

Verified date October 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of HealthTaiwan: National Bureau of Controlled Drugs
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date November 2010
Est. primary completion date November 2010
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 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
Estazolam
oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total score of Pittsburgh Sleep Quality Index (PSQ) 3 weeks No
Secondary Physician's clinical global impression (CGI) 3 weeks No
Secondary Patient's global impression (PG) 3 weeks No
Secondary Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary 3 weeks No
Secondary Incidence and severity of adverse events, including abnormal sleep behavior 3 weeks Yes
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