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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014