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A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Insomnia

Intervention: Eszopiclone 1 mg (Drug); Eszopiclone 2 mg (Drug); Eszopiclone 3 mg (Drug); Placebo (Drug); Zolpidem Tartrate 10 mg (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Eisai Co., Ltd.

Official(s) and/or principal investigator(s):
Atsushi Kamijo, Study Director, Affiliation: New Product Development Department, Clinical Research Center

Summary

The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.

Clinical Details

Official title: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Latency To Persistent Sleep (LPS)

Sleep Latency (SL)

Secondary outcome:

Total Sleep Time (Objective & Subjective)

Sleep Efficiency

Wake Time After Sleep Onset (WASO)- Objective & Subjective

Number of Awakenings (Objective & Subjective)

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10 prespecified treatment sequence patterns.

Eligibility

Minimum age: 21 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent 2. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

- Sleep latency of more than or equal to 30 minutes for more than or equal to 3

days a week

- Total sleep time of less than or equal to 390 minutes for more than or equal to

3 days a week 3. Participants who meet both of the following based on polysomnogram (PSG) in observation period:

- Objective sleep latency of more than or equal to 20 minutes for 2 consecutive

PSG days

- Objective total sleep time of less than or equal to 420 minutes for 2

consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days Exclusion Criteria: 1. Participants with comorbid primary sleep disorders (e. g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia. 2. Participants with insomnia caused by pharmacological actions (drug-induced insomnia). 3. Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s). 4. Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version. 5. Participants with organic mental disorder.

Locations and Contacts

Akita, Japan

Fukuoka, Japan

Gifu, Japan

Hiroshima, Japan

Kagoshima, Japan

Kochi, Japan

Kumamoto, Japan

Kyoto, Japan

Osaka, Japan

Toyohashi, Aichi, Japan

Kitakyushu, Fukuoka, Japan

Kurume, Fukuoka, Japan

Otaru, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Kawasaki, Kanagawa, Japan

Urazoe, Okinawa, Japan

Sakai, Osaka, Japan

Kodaira, Tokyo, Japan

Setagaya, Tokyo, Japan

Shibuya, Tokyo, Japan

Additional Information

Starting date: September 2008
Last updated: December 28, 2012

Page last updated: August 23, 2015

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