Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 138 for:    ZOLPIDEM

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181232
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : September 10, 2014
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE August 4, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date September 10, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
  • Rest/activity cycles measured by Actigraphy [ Time Frame: 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
  • Physician's clinical global impression (CGI) [ Time Frame: 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) ]
  • Sleep latency as derived from sleep diary [ Time Frame: 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) ]
  • Total sleep time as derived from sleep diary [ Time Frame: 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) ]
  • Day time function as assessed by Epworth Sleepiness Scale (ESS) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Initiation and Maintenance Disorders
  • Primary Insomnia
Intervention  ICMJE
  • Drug: Zolpidem MR
    oral
    Other Names:
    • Stilnox CR
    • Ambient CR
  • Drug: Zolpidem IR
    oral
    Other Name: Stilnox
Study Arms  ICMJE
  • Experimental: MR low-dose group
    Intervention: Drug: Zolpidem MR
  • Experimental: MR high-dose group
    Intervention: Drug: Zolpidem MR
  • Active Comparator: IR group
    Intervention: Drug: Zolpidem IR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2011)
132
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2010)
180
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01181232
Other Study ID Numbers  ICMJE STCR-0901-TW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Astellas Pharma Taiwan, Inc.
Investigators  ICMJE
Study Chair: Use Central Contact Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP