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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-3262 | Registry Identifier | WHO |
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The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
Zolpidem is the most commonly prescribed hypnotic in the United States for patients suffering from insomnia.
The purpose of this study is to assess whether ramelteon therapy can facilitate the discontinuation of benzodiazepine therapy in long term users. Subject participation in this study is anticipated to be about 17 weeks.
Subjects were screened and enrolled in a 4-week placebo run-in period, may have been randomized to a 10-week double-blind treatment period, and may have completed with a 2-week open-label treatment period. In the double-blind treatment period, subjects were randomized to one of two treatments: either ramelteon 8 mg tablets taken orally once-daily with concomitant current zolpidem therapy or to placebo-matching tablets once daily with concomitant current zolpidem therapy. Subjects incrementally reduced zolpidem therapy by dose, frequency, or both for up to 10 weeks. Only those subjects who completed the double-blind treatment period and had achieved a 50% reduction in zolpidem therapy during the double-blind treatment period participated in the open-label treatment period in which 8 mg ramelteon was administered. Zolpidem consumed during the open-label treatment period was recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon 8 mg QD and current Zolpidem therapy | Experimental | Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. |
|
| Placebo QD and current Zolpidem therapy | Placebo Comparator | Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon and zolpidem | Drug | Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Discontinued Zolpidem Therapy | Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2 | Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. | Baseline and Weeks 1-2 |
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Inclusion Criteria
Exclusion Criteria
Known hypersensitivity to ramelteon, zolpidem, or melatonin.
Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication.
Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication.
History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
History of drug addiction or drug abuse within the past 12 months.
History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes more than 2 alcoholic drinks per day.
Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of run-in study medication.
Body mass index of less than 18 or greater than 34 (weight /height2).
Any clinically important abnormal finding as documented by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
Positive hepatitis panel.
Known history of human immunodeficiency virus.
Any additional conditions(s) that in the investigator's opinion would affect:
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda Global Research & Development Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hot Springs | Arkansas | United States | ||||
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| Label | URL |
|---|---|
| Rozerem Package Insert | View source |
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Subjects completed a 4-week single-blind placebo run-in period prior to randomization in the double-blind treatment period (DBTP). During this time they took placebo-matching tablets once-daily (QD) with concomitant current zolpidem therapy. Subjects used a daily subject diary to record zolpidem dose reduction, daily activities, and sleep quality.
Subjects were enrolled at 38 investigative sites in the United States from 26 April 2007 to 28 May 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon 8 mg QD | Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP. |
| FG001 | Placebo QD | Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo Run-in |
|
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| Placebo and zolpidem | Drug | Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks. |
|
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| Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4 |
Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. |
| Baseline and Weeks 3-4 |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6 | Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. | Baseline and Weeks 5-6 |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8 | Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized. | Baseline and Weeks 7-8 |
| Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10 | Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. | Baseline and Weeks 9-10 |
| Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2 | The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized. | Baseline and Weeks 1-2 |
| Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4 | The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Weeks 3-4 |
| Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6 | The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Weeks 5-6 |
| Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8 | The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Baseline and Weeks 7-8 |
| Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10 | The number of nights zolpidem was taken was recorded during Weeks 9-10 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Baseline and Weeks 9-10 |
| Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation | Participants who took no zolpidem during the last 7 days of the DBTP were completely discontinued from zolpidem. Participants who completely discontinued zolpidem via reduction in zolpidem use frequency (alone) were not summarized. | Weeks 1-10 |
| Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period | Participants who achieved a 50% reduction in zolpidem dosage (or frequency) at the end of the DBTP (ie, the end of Reduction Phase 4) were summarized. The reduction in dosage at Reduction Phase 4=[1-(Reduction Phase 4 weekly dosage/baseline weekly dosage)]*100%. | Baseline and Week 10 |
| Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period | Participants who achieved a 50% reduction in zolpidem dosage at any previously defined 2-week period (ie, reduction phase) during the DBTP were summarized. The reduction in dosage at any time=[1-(reduction phase weekly dosage/baseline weekly dosage)]*100%. | Baseline and Weeks 1-10 |
| Anaheim |
| California |
| United States |
| Fountain Valley | California | United States |
| La Mesa | California | United States |
| Los Angeles | California | United States |
| Redlands | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Santa Monica | California | United States |
| Denver | Colorado | United States |
| Clearwater | Florida | United States |
| Hollywood | Florida | United States |
| Kissimmee | Florida | United States |
| Naples | Florida | United States |
| Pembroke Pines | Florida | United States |
| Winter Park | Florida | United States |
| Atlanta | Georgia | United States |
| Austell | Georgia | United States |
| Boise | Idaho | United States |
| Louisville | Kentucky | United States |
| Metairie | Louisiana | United States |
| Chevy Chase | Maryland | United States |
| St Louis | Missouri | United States |
| Lincoln | Nebraska | United States |
| New York | New York | United States |
| West Seneca | New York | United States |
| Raleigh | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Toledo | Ohio | United States |
| Portland | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| Greer | South Carolina | United States |
| Fayetteville | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| San Angelo | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Double-Blind Treatment |
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| Open-Label Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon 8 mg QD | Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP. |
| BG001 | Placebo QD | Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| Race/Ethnicity, Customized | Number | Subjects |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Baseline average total daily zolpidem dosage | Number | subjects |
| ||||||||||||||||
| Use of pharmacological assistance to sleep | Randomized subjects responded to the question, "How often per week do you use pharmacological assistance to sleep?" 4=4 nights/week; >4=5-7 nights/week. | Number | subjects |
| |||||||||||||||
| Weekly frequency zolpidem consumption | The average number of nights per week subjects took zolpidem was calculated. | Number | subjects |
| |||||||||||||||
| Baseline weekly zolpidem dosage | Baseline for the weekly zolpidem dosage was calculated as the total amount zolpidem intake recorded by a subject during placebo run-in, divided by the number of days in the period, multiplied by 7. Ramelteon 8 mg n=64; Placebo n=70. | Mean | Standard Deviation | Dosage (mg) |
| ||||||||||||||
| Weekly frequency zolpidem consumption | Average number of nights per week randomized subjects used zolpidem. Ramelteon 8 mg n=64; Placebo n=70. | Mean | Standard Deviation | nights per week |
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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 | Percentage of Participants Who Discontinued Zolpidem Therapy | Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Number | Percentage of participants | Week 10 |
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| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2 | Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | Dose (mg) | Baseline and Weeks 1-2 |
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| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4 | Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | Dose (mg) | Baseline and Weeks 3-4 |
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| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6 | Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | Dose (mg) | Baseline and Weeks 5-6 |
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| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8 | Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | Dose (mg) | Baseline and Weeks 7-8 |
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| Secondary | Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10 | Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | Dose (mg) | Baseline and Weeks 9-10 |
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| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2 | The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | nights per week | Baseline and Weeks 1-2 |
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| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4 | The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | nights per week | Weeks 3-4 |
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| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6 | The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | nights per week | Weeks 5-6 |
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| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8 | The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | nights per week | Baseline and Weeks 7-8 |
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| Secondary | Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10 | The number of nights zolpidem was taken was recorded during Weeks 9-10 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Least Squares Mean | Standard Error | nights per week | Baseline and Weeks 9-10 |
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| Secondary | Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation | Participants who took no zolpidem during the last 7 days of the DBTP were completely discontinued from zolpidem. Participants who completely discontinued zolpidem via reduction in zolpidem use frequency (alone) were not summarized. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, had completed the DBTP, and had sufficient zolpidem dosage data in the last 7 days of the DBTP. Estimates could not be reported with correct statistical inference due to small sample sizes by method of discontinuation (ie, most subjects reduced zolpidem dose). | Posted | Number | participants | Weeks 1-10 |
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| Secondary | Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period | Participants who achieved a 50% reduction in zolpidem dosage (or frequency) at the end of the DBTP (ie, the end of Reduction Phase 4) were summarized. The reduction in dosage at Reduction Phase 4=[1-(Reduction Phase 4 weekly dosage/baseline weekly dosage)]*100%. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP. | Posted | Number | participants | Baseline and Week 10 |
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| Secondary | Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period | Participants who achieved a 50% reduction in zolpidem dosage at any previously defined 2-week period (ie, reduction phase) during the DBTP were summarized. The reduction in dosage at any time=[1-(reduction phase weekly dosage/baseline weekly dosage)]*100%. | Analysis was performed on all subjects who were randomized and received at least 1 dose of double-blind medication during the study. Subjects were analyzed by the treatment they were randomized to receive. | Posted | Number | participants | Baseline and Weeks 1-10 |
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Treatment-emergent adverse events with onset dates the same or after the start of double-blind study medication and before the first dose of open-label study medication were summarized for the double-blind medication.
Two ramelteon-treated subjects permanently discontinued the study due to adverse events during the double-blind treatment period. One placebo-treated subject had multiple temporary study drug interruptions due to adverse events but did not permanently discontinue the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon 8 mg QD | Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP. | 0 | 64 | 11 | 64 | ||
| EG001 | Placebo QD | Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP. | 1 | 70 | 7 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 150 days to permit actions necessary to preserve sponsor's intellectual property; can request changes to the results communication only for the purpose of removing non study related information that is proprietary and confidential to sponsor; can require delay of a results communication until the study has been completed at all participating sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C495910 | ramelteon |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Lack of Efficacy |
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| Other |
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| Randomized not treated |
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| Male |
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| Black or African American |
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| White |
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| Multiracial |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| >10 mg |
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| Information not available |
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| >4 nights per week |
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| 4 nights per week |
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| 5 nights per week |
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| 6 nights per week |
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| 7 nights per week |
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| Information not available |
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