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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00956319
First received: August 9, 2009
Last updated: October 5, 2011
Last verified: October 2011
History of Changes

August 9, 2009
October 5, 2011
May 2009
November 2010   (final data collection date for primary outcome measure)
Total score of Pittsburgh Sleep Quality Index (PSQ) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00956319 on ClinicalTrials.gov Archive Site
  • Physician's clinical global impression (CGI) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Patient's global impression (PG) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events, including abnormal sleep behavior [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients
A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients With Primary Insomnia

The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Initiation and Maintenance Disorders
  • Primary Insomnia
  • Drug: Zolpidem MR
    oral
    Other Names:
    • Stilnox CR
    • Ambient CR
  • Drug: Estazolam
    oral
    Other Name: Eurodin
  • Experimental: Zolpidem group
    Intervention: Drug: Zolpidem MR
  • Active Comparator: Estazolam group
    Intervention: Drug: Estazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
November 2010
November 2010   (final data collection date for primary outcome measure)

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 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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00956319
STCR-0802-TW
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2011

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