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

September 9, 2014 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MR low-dose group
Drug: Zolpidem MR
oral
Other Names:
  • Stilnox CR
  • Ambient CR
Experimental: MR high-dose group
Drug: Zolpidem MR
oral
Other Names:
  • Stilnox CR
  • Ambient CR
Active Comparator: IR group
Drug: Zolpidem IR
oral
Other Names:
  • Stilnox

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Physician's clinical global impression (CGI)
Time Frame: For 2 weeks (Day 0, Day 7, Day 14)
For 2 weeks (Day 0, Day 7, Day 14)
Patient's global impression (PGI)
Time Frame: For 2 weeks (Day 0, Day 7, Day 14)
For 2 weeks (Day 0, Day 7, Day 14)
Sleep latency as derived from sleep diary
Time Frame: For 2 weeks (Day 0, Day 7, Day 14)
For 2 weeks (Day 0, Day 7, Day 14)
Number of awakenings as derived from sleep diary
Time Frame: For 2 weeks (Day 0, Day 7, Day 14)
For 2 weeks (Day 0, Day 7, Day 14)
Total sleep time as derived from sleep diary
Time Frame: For 2 weeks (Day 0, Day 7, Day 14)
For 2 weeks (Day 0, Day 7, Day 14)
Wake time after sleep onset as derived from sleep diary
Time Frame: For 2 weeks (Day 0, Day 7, Day 14)
For 2 weeks (Day 0, Day 7, Day 14)
Day time function as assessed by Epworth Sleepiness Scale (ESS)
Time Frame: For 2 weeks (Day 0, Day 7, Day 14)
For 2 weeks (Day 0, Day 7, Day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Taiwan, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 12, 2010

First Posted (Estimate)

August 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STCR-0901-TW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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