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:	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:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	48
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Zolpidem group: Experimental	Drug: Zolpidem MR oral
Estazolam group: Active Comparator	Drug: Estazolam oral

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

Contacts

Contact: Clinical Development Administration Department

clinicaltrials_info@jp.astellas.com

Locations

Taiwan
	Recruiting
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. ( Director )
Study ID Numbers:	STCR-0802-TW
Study First Received:	August 9, 2009
Last Updated:	August 9, 2009
ClinicalTrials.gov Identifier:	NCT00956319 History of Changes
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
Zolpidem
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Depressants
Dyssomnias
Sleep Disorders

Pharmacologic Actions
Sleep Disorders, Intrinsic
Estazolam
Mental Disorders
GABA Agonists
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010