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The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone 1 mg | Experimental |
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| Eszopiclone 2 mg | Experimental |
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| Eszopiclone 3 mg | Experimental |
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| Placebo | Placebo Comparator |
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| Zolpidem Tartrate 10 mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone 1 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time (Objective & Subjective) | Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective total sleep time was based on PSG-based assessments. 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. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period. |
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Inclusion Criteria:
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:
Participants who meet both of the following based on polysomnogram (PSG) in observation period:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atsushi Kamijo | New Product Development Department, Clinical Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyohashi | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23063301 | Derived | 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. |
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Of the 192 participants who entered the screening period, 72 were randomized to study medication (excluding 119 ineligible participants; one withdrawal of consent).
This study was recruited at 21 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population | Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first. Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7) A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Eszopiclone 2 mg | Drug | 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. |
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| Eszopiclone 3 mg | Drug | 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. |
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| Placebo | Drug | 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. |
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| Zolpidem Tartrate 10 mg | Drug | 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. |
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| 10 days (5 intervals of two consecutive nights) |
| Sleep Efficiency | Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent. 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 patient'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) |
| Wake Time After Sleep Onset (WASO)- Objective & Subjective | Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective WASO was based on PSG assessments. 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. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were 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) |
| Number of Awakenings (Objective & Subjective) | Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective number of awakenings was based on PSG assessments. 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. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were 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) |
| Akita |
| Akita |
| Japan |
| Fukuoka | Fukuoka | Japan |
| Kitakyushu | Fukuoka | Japan |
| Kurume | Fukuoka | Japan |
| Gifu | Gifu | Japan |
| Hiroshima | Hiroshima | Japan |
| Otaru | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Kawasaki | Kanagawa | Japan |
| Kochi | Kochi | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Urazoe | Okinawa | Japan |
| Osaka | Osaka | Japan |
| Sakai | Osaka | Japan |
| Kodaira | Tokyo | Japan |
| Setagaya City | Tokyo | Japan |
| Shibuya City | Tokyo | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first. Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7) A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals. | Posted | Mean | Standard Deviation | Minutes | 10 days (5 intervals of two consecutive nights) |
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| Secondary | Total Sleep Time (Objective & Subjective) | Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective total sleep time was based on PSG-based assessments. 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. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period. | Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals. | Posted | Median | Full Range | Minutes | 10 days (5 intervals of two consecutive nights) |
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| Secondary | Sleep Efficiency | Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent. 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 patient'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. | Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals. | Posted | Median | Full Range | Percentage of time asleep of 8 hours | 10 days (5 intervals of two consecutive nights) |
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| Secondary | Wake Time After Sleep Onset (WASO)- Objective & Subjective | Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective WASO was based on PSG assessments. 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. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period. | Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals. | Posted | Median | Full Range | Minutes | 10 days (5 intervals of two consecutive nights) |
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| Secondary | Number of Awakenings (Objective & Subjective) | Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment. The objective number of awakenings was based on PSG assessments. 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. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert. The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period. | Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals. | Posted | Median | Full Range | Number of awakenings | 10 days (5 intervals of two consecutive nights) |
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| Primary | 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. | Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals. | Posted | Mean | Standard Deviation | Minutes | 10 days (5 intervals of two consecutive nights) |
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Safety population included randomized participants who were administered >= 1 dose of study medication and had any evaluable safety data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. | 0 | 71 | 5 | 71 | ||
| EG001 | Eszopiclone 1 mg | Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. | 0 | 70 | 10 | 70 | ||
| EG002 | Eszopiclone 2 mg | Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. | 0 | 69 | 10 | 69 | ||
| EG003 | Eszopiclone 3 mg | Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. | 0 | 68 | 17 | 68 | ||
| EG004 | Zolpidem Tartrate 10 mg | Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. | 0 | 70 | 8 | 70 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders |
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| Somnolence | Nervous system disorders |
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| Dizziness | Nervous system disorders |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders |
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| Feeling Abnormal | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Atsushi Kamijo, Study Director | Eisai Co., Ltd. | +81-3-3817-5245 | a-kamijo@hhc.eisai.co.jp |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D011725 | Pyridines |
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Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
| OG002 | Eszopiclone 2 mg | Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG003 | Eszopiclone 3 mg | Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG004 | Zolpidem Tartrate 10 mg | Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
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| OG002 | Eszopiclone 2 mg | Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG003 | Eszopiclone 3 mg | Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG004 | Zolpidem Tartrate 10 mg | Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
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| OG002 | Eszopiclone 2 mg | Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG003 | Eszopiclone 3 mg | Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG004 | Zolpidem Tartrate 10 mg | Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
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Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
| OG002 | Eszopiclone 2 mg | Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG003 | Eszopiclone 3 mg | Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG004 | Zolpidem Tartrate 10 mg | Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
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| OG003 | Eszopiclone 3 mg | Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
| OG004 | Zolpidem Tartrate 10 mg | Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns. |
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