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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01181232
First received: August 4, 2010
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Primary Insomnia
 Drug: Zolpidem MR
Drug: Zolpidem IR
 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, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) 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:
  • Rest/activity cycles measured by Actigraphy [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]
  • Total score of Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician's clinical global impression (CGI) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]
  • Patient's global impression (PGI) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]
  • Sleep latency as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]
  • Number of awakenings as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]
  • Total sleep time as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]
  • Wake time after sleep onset as derived from sleep diary [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: No ]
  • Day time function as assessed by Epworth Sleepiness Scale (ESS) [ Time Frame: For 2 weeks (Day 0, Day 7, Day 14) ] [ Designated as safety issue: Yes ]

Enrollment: 132
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Stilnox

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181232

Locations
Taiwan
Tainan, Taiwan, 704
Taipei, Taiwan, 100
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01181232     History of Changes
Other Study ID Numbers: STCR-0901-TW
Study First Received: August 4, 2010
Last Updated: October 5, 2011
Health Authority: Taiwan: National Bureau of Controlled Drugs

Keywords provided by Astellas Pharma Inc:
insomnia
zolpidem

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

ClinicalTrials.gov processed this record on May 16, 2013