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

Primary Purpose

Sleep Initiation and Maintenance Disorders, Primary Insomnia

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Zolpidem MR
Zolpidem IR
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring insomnia, zolpidem

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

MR low-dose group

MR high-dose group

IR group

Arm Description

Outcomes

Primary Outcome Measures

Rest/activity cycles measured by Actigraphy
Total score of Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Physician's clinical global impression (CGI)
Patient's global impression (PGI)
Sleep latency as derived from sleep diary
Number of awakenings as derived from sleep diary
Total sleep time as derived from sleep diary
Wake time after sleep onset as derived from sleep diary
Day time function as assessed by Epworth Sleepiness Scale (ESS)

Full Information

First Posted
August 4, 2010
Last Updated
September 9, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01181232
Brief Title
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Primary Insomnia
Keywords
insomnia, zolpidem

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR low-dose group
Arm Type
Experimental
Arm Title
MR high-dose group
Arm Type
Experimental
Arm Title
IR group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zolpidem MR
Other Intervention Name(s)
Stilnox CR, Ambient CR
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Zolpidem IR
Other Intervention Name(s)
Stilnox
Intervention Description
oral
Primary Outcome Measure Information:
Title
Rest/activity cycles measured by Actigraphy
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Title
Total score of Pittsburgh Sleep Quality Index (PSQI)
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Secondary Outcome Measure Information:
Title
Physician's clinical global impression (CGI)
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Title
Patient's global impression (PGI)
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Title
Sleep latency as derived from sleep diary
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Title
Number of awakenings as derived from sleep diary
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Title
Total sleep time as derived from sleep diary
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Title
Wake time after sleep onset as derived from sleep diary
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)
Title
Day time function as assessed by Epworth Sleepiness Scale (ESS)
Time Frame
For 2 weeks (Day 0, Day 7, Day 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140534 in the JapicCTI-RNo. field

Learn more about this trial

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

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