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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
  Purpose

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.


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Primary Insomnia
 Drug: Zolpidem MR
Drug: Estazolam
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Insomnia
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Total score of Pittsburgh Sleep Quality Index (PSQ) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zolpidem group Drug: Zolpidem MR
oral
Other Names:
  • Stilnox CR
  • Ambient CR
Active Comparator: Estazolam group Drug: Estazolam
oral
Other Name: Eurodin

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956319

Locations
Taiwan
Taipei, Taiwan, 100
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00956319     History of Changes
Other Study ID Numbers: STCR-0802-TW
Study First Received: August 9, 2009
Last Updated: October 5, 2011
Health Authority: Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs

Keywords provided by Astellas Pharma Inc:
Insomnia
Zolpidem
Estazolam

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Estazolam
Zolpidem
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
GABA-A Receptor Agonists
GABA Agonists

ClinicalTrials.gov processed this record on May 23, 2013