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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181232
• Other study ID #: STCR-0901-TW
• 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

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

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

External Links

•   Link to Results on JAPIC - enter 140534 in the JapicCTI-RNo. field