A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia

NCT ID: NCT00999219

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-07-31

Brief Summary

This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FK199B-first group

Group Type: EXPERIMENTAL

FK199B

Intervention Type: DRUG

oral

Zolpidem

Intervention Type: DRUG

oral

Zolpidem-first group

Group Type: EXPERIMENTAL

FK199B

Intervention Type: DRUG

oral

Zolpidem

Intervention Type: DRUG

oral

Interventions

FK199B

oral

Intervention Type: DRUG

Zolpidem

oral

Intervention Type: DRUG

Other Intervention Names

Zolpidem MR Tablet; Myslee

Eligibility Criteria

Inclusion Criteria

• Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
• Patients complaining of insomnia continuously for 4 weeks or longer
• Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening
• Patient on most occasions sleeps for a total of ≥3 and <6.5 hours over the 4 week period prior to initial screening
• Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening
• Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and <30

Exclusion Criteria

• Patients with schizophrenia or manic-depressive psychosis
• Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic
• Patients with circadian rhythm sleep disorder
• Patient works night shifts
• Patients with alcoholic sleep disorder
• Patients with alcohol or drug dependence or a history of these
• Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs
• Patients with sleep apnea syndrome
• Patients with restless legs syndrome or periodic limb movement disorder
• Patients with epileptic insomnia
• Patients smoke on average 40 or more cigarettes a day
• Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Chūbu, , Japan

Hokkaido, , Japan

Kansai, , Japan

Kantou, , Japan

Kyushu, , Japan

Shikoku, , Japan

Tōhoku, , Japan

Countries

Japan

Other Identifiers

6199-CL-0006

Identifier Type: -

Identifier Source: org_study_id