A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients

Sleep Initiation and Maintenance Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956319
• Other study ID #: STCR-0802-TW
• 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

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

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