A Study to Compare Efficacy and Safety of Zolpidem Modifi... | NCT01181232

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

NCT01181232

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Sep 10, 2014Estimated

Enrollment

132Actual

Phase

Phase 4

Conditions

Sleep Initiation and Maintenance Disorders
Primary Insomnia

Interventions

Zolpidem MR
Zolpidem IR

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Aug 4, 2010

First Submission Date that Met QC Criteria

Aug 12, 2010

First Posted Date

Aug 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2014

Last Update Posted Date

Sep 10, 2014Estimated

Name	Class
Astellas Pharma Taiwan, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
MR low-dose group	Experimental	Drug: Zolpidem MR
MR high-dose group	Experimental	Drug: Zolpidem MR
IR group	Active Comparator	Drug: Zolpidem IR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zolpidem MR	Drug	oral	MR high-dose group MR low-dose group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rest/activity cycles measured by Actigraphy		For 2 weeks (Day 0, Day 7, Day 14)
Total score of Pittsburgh Sleep Quality Index (PSQI)		For 2 weeks (Day 0, Day 7, Day 14)

Secondary Outcomes

Measure	Description	Time Frame
Physician's clinical global impression (CGI)		For 2 weeks (Day 0, Day 7, Day 14)
Patient's global impression (PGI)		For 2 weeks (Day 0, Day 7, Day 14)
Sleep latency as derived from sleep diary

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077334	Zolpidem

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Tainan		704	Taiwan