NCT00770510

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 4, 2013

Completed
Last Updated

February 4, 2013

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

October 9, 2008

Results QC Date

December 28, 2012

Last Update Submit

December 28, 2012

Conditions

Primary Insomnia

Keywords

Primary insomnia

Outcome Measures

Primary Outcomes (2)

  • Latency To Persistent Sleep (LPS)

    The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.

    10 days (5 intervals of two consecutive nights)

  • Sleep Latency (SL)

    The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.

    10 days (5 intervals of two consecutive nights)

Secondary Outcomes (4)

  • Total Sleep Time (Objective & Subjective)

    10 days (5 intervals of two consecutive nights)

  • Sleep Efficiency

    10 days (5 intervals of two consecutive nights)

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

    10 days (5 intervals of two consecutive nights)

  • Number of Awakenings (Objective & Subjective)

    10 days (5 intervals of two consecutive nights)

Study Arms (5)

Eszopiclone 1 mg

EXPERIMENTAL
Drug: Eszopiclone 1 mg

Eszopiclone 2 mg

EXPERIMENTAL
Drug: Eszopiclone 2 mg

Eszopiclone 3 mg

EXPERIMENTAL
Drug: Eszopiclone 3 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Zolpidem Tartrate 10 mg

ACTIVE COMPARATOR
Drug: Zolpidem Tartrate 10 mg

Interventions

Eszopiclone 1 mgDRUG

Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Also known as: SEP-190
Eszopiclone 1 mg
Eszopiclone 2 mgDRUG

Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Also known as: SEP-190
Eszopiclone 2 mg
Eszopiclone 3 mgDRUG

Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Also known as: SEP-190
Eszopiclone 3 mg
PlaceboDRUG

Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Placebo
Zolpidem Tartrate 10 mgDRUG

Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Zolpidem Tartrate 10 mg

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
  • 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
  • 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

You may not qualify if:

  • 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.
  • Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
  • Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
  • Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
  • Participants with organic mental disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Toyohashi, Aichi-ken, Japan

Location

Unknown Facility

Akita, Akita, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, Japan

Location

Unknown Facility

Kurume, Fukuoka, Japan

Location

Unknown Facility

Gifu, Gifu, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Otaru, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, Japan

Location

Unknown Facility

Kochi, Kochi, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Urazoe, Okinawa, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Sakai, Osaka, Japan

Location

Unknown Facility

Kodaira, Tokyo, Japan

Location

Unknown Facility

Setagaya City, Tokyo, Japan

Location

Unknown Facility

Shibuya City, Tokyo, Japan

Location

Related Publications (1)

  • Uchimura N, Kamijo A, Kuwahara H, Uchiyama M, Shimizu T, Chiba S, Inoue Y. A randomized placebo-controlled polysomnographic study of eszopiclone in Japanese patients with primary insomnia. Sleep Med. 2012 Dec;13(10):1247-53. doi: 10.1016/j.sleep.2012.08.015. Epub 2012 Oct 11.

    PMID: 23063301DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

EszopicloneZolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPyridines

Results Point of Contact

Title
Atsushi Kamijo, Study Director
Organization
Eisai Co., Ltd.
a-kamijo@hhc.eisai.co.jp
+81-3-3817-5245

Study Officials

  • Atsushi Kamijo

    New Product Development Department, Clinical Research Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 4, 2013

Results First Posted

February 4, 2013

Record last verified: 2012-12

Locations

JP(20)