A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00956319

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 IV

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:

Drug Information available for: Estazolam Zolpidem

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 February 09, 2012