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Lack of enrollment.
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| Name | Class |
|---|---|
| Takeda Pharmaceuticals North America, Inc. | INDUSTRY |
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This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.
Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Placebo) | Placebo Comparator | Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. |
|
| 2 (Ramelteon) | Active Comparator | Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo taken 30 minutes before bedtime days 1-28 of treatment period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed). | Every morning during the screening, treatment, and withdrawal periods |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Sleep Parameters - Total Sleep Time | The subject reports how many hours of sleep she got. | Every morning during the screening, treatment, and withdrawal periods |
| Quantitative Sleep Parameters - Number of Awakenings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward J. Stepanski, Ph.D. | Accelerated Community Oncology Research Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Cancer Center | Hot Springs | Arkansas | 71913 | United States | ||
| Wilshire Oncology Medical Group, Inc. |
After consent, subjects underwent a 2 week screening period to see if they met the criteria for insomnia and to assess compliance with daily Interactive Voice Recognition System (IVRS) calls.
10 community oncology research sites across the United States within Accelerated Community Oncology Research Network (ACORN) participated in this study. Enrollment started in August 2006 and closed in August 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 (Placebo) | Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. |
| FG001 | 2 (Ramelteon) | Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period (Pre-randomization) |
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| Treatment Period |
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| Withdrawal Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 (Placebo) | Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. |
| BG001 | 2 (Ramelteon) | Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Sleep Efficiency | Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed). | Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon. | Posted | Mean | Standard Deviation | Percent sleep efficiency | Every morning during the screening, treatment, and withdrawal periods |
|
Adverse event data were collected beginning at Visit 2: Randomization Visit (Day 1) until Visit 4: Close-out Visit (Day 36).
Systematic Assessment - subjects were assessed for adverse events at each study visit by either the research coordinator, treating physician, or other appropriate sub-investigator (such as a nurse practitioner or physician assistant).
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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 | 1 (Placebo) | Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
Early study termination due to slow enrollment; Small sample size analyzed; Some IVRS and Patient Care Monitor (PCM) data were lost and could not be retrieved; Some subject non-compliance with study requirements
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Scientific Affairs | Accelerated Community Oncology Research Network, Inc. | mwalker@acorncro.com |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| Ramelteon |
| Drug |
8 mgs daily for days 1-28 of treatment period |
|
|
The subject reports how many times she woke up during the night.
| Every morning during the screening, treatment, and withdrawal periods |
| Qualitative Evaluation of Sleep - Global Sleep Impression | The Patient Global Impression is a 7-point scale which asks "How much has your sleep improved?" with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement. | Once during the withdrawal period |
| Qualitative Evaluation of Sleep - Quality of Sleep | The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep. | Every morning during the screening, treatment, and withdrawal periods |
| Daytime Function - Fatigue | The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible. | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments |
| Daytime Function - Despair | The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair. | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments |
| Daytime Function - Distress | The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress. | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments |
| La Verne |
| California |
| 91750 |
| United States |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Augusta Oncology Associates, PC | Augusta | Georgia | 30901 | United States |
| North Idaho Cancer Center | Coeur d'Alene | Idaho | 83814 | United States |
| Hematology Oncology Centers of the Northern Rockies | Billings | Montana | 59101 | United States |
| Tri-County Hematology & Oncology Associates | Canton | Ohio | 44718 | United States |
| Pottsville Cancer Center | Pottsville | Pennsylvania | 17901 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Cancer Specialists of Tidewater, Ltd. | Chesapeake | Virginia | 23320 | United States |
| Screen failure |
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| COMPLETED |
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| NOT COMPLETED |
|
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| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| 2 (Ramelteon) |
Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. |
|
|
| Secondary | Quantitative Sleep Parameters - Total Sleep Time | The subject reports how many hours of sleep she got. | Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon. | Posted | Mean | Standard Deviation | Hours | Every morning during the screening, treatment, and withdrawal periods |
|
|
|
| Secondary | Quantitative Sleep Parameters - Number of Awakenings | The subject reports how many times she woke up during the night. | Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon. | Posted | Mean | Standard Deviation | Awakenings | Every morning during the screening, treatment, and withdrawal periods |
|
|
|
| Secondary | Qualitative Evaluation of Sleep - Global Sleep Impression | The Patient Global Impression is a 7-point scale which asks "How much has your sleep improved?" with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement. | Posted | Number | Participants | Once during the withdrawal period |
|
|
|
| Secondary | Qualitative Evaluation of Sleep - Quality of Sleep | The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep. | Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon. | Posted | Mean | Standard Deviation | Units on a Scale | Every morning during the screening, treatment, and withdrawal periods |
|
|
|
| Secondary | Daytime Function - Fatigue | The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible. | Screening period: 12 patients with 6 treated with Placebo and 6 with Ramelteon. Treatment period: 11 patients with 4 treated with Placebo and 7 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon. | Posted | Mean | Standard Deviation | Units on a Scale | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments |
|
|
|
| Secondary | Daytime Function - Despair | The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair. | Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon. | Posted | Mean | Standard Deviation | Units on a Scale | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments |
|
|
|
| Secondary | Daytime Function - Distress | The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress. | Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon. | Posted | Mean | Standard Deviation | Units on a Scale | Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments |
|
|
|
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | 2 (Ramelteon) | Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. | 0 | 9 | 4 | 9 |
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Leg edema | General disorders | Systematic Assessment |
|
| Pain on right side of chest | General disorders | Systematic Assessment |
|
| Abscess on right hip | Infections and infestations | Systematic Assessment |
|
| Sinus infection | Infections and infestations | Systematic Assessment |
|
| Yeast infection | Infections and infestations | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory virus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
PI must provide Sponsor an advance copy of any proposed publication whether in journals or in conferences or other public forum at least 60 days prior to any submission for publication or public presentation so that Sponsor may determine whether it contains any Confidential Information of Sponsor, and/or any discovery or invention is made.
| D001523 |
| Mental Disorders |
| Withdrawal Period |
|
| Withdrawal Period |
|
| Slight improvement |
|
| Minimal improvement |
|
| No improvement |
|
| Withdrawal Period |
|
| Withdrawal Period |
|
| Withdrawal Period |
|
| Withdrawal Period |
|