Efficacy of Ramelteon in Adults With Chronic Insomnia
Primary Purpose
Chronic Insomnia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Sleep Disorder, Drug Therapy
Eligibility Criteria
Inclusion Criteria
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Has had primary chronic insomnia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months.
- Reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time less than 6.5 hours.
- Habitual bedtime is between 10:00 PM and 1:00 AM.
- Willing to have a fixed bedtime and agrees to go to bed within plus or minus 30 minutes of the habitual bedtime during the entire study.
- Consistent access to a touch tone phone and are willing to complete telephone questionnaires twice daily during participation in the study.
- Willing to remain in bed for at least 6.5 hours each night during the entire study.
- Used pharmacological assistance to sleep 0-4 times per week in the last 3 months.
- Must complete the morning questionnaire on at least 4 of the first 7 mornings after Screening Visit 1.
- On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective sleep latency of greater than or equal to 45 minutes.
- On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective total sleep time of less than 6.5 hours.
Exclusion Criteria
- Known hypersensitivity to ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan.
- Participated in any other investigational study and/or took any investigational drug within 30 days prior to the first dose of single-blind study medication.
- Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication.
- Has flown across greater than 3 time zones within 7 days prior to screening, or will travel across 2 or more time zones during the course of the study.
- Participated in a weight loss program or has substantially altered exercise routine within 30 days prior to the first night of singleblind study medication.
- Ever had a history of seizures, sleep apnea, and/or chronic obstructive pulmonary disease.
- History of psychiatric disorder within the past 6 months.
- History of fibromyalgia.
- 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, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
- Uses tobacco products or any other products that may interfere with the sleep wake cycle during nightly awakenings.
- Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- Positive hepatitis panel.
Any additional condition(s) that in the Investigator's opinion would:
- affect sleep/wake function
- prohibit the subject from completing the study
- indicate that continuation in the study would not be in the best interests of the subject.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
- Anxiolytics
- Central nervous system active drugs
- Hypnotics
- Narcotic analgesics
- Antidepressants
- Beta blockers
- Anticonvulsants
- St. John's Wort
- Sedating H1 antihistamines
- Kava-kava
- Systemic steroids
- Ginkgo-biloba
- Respiratory stimulants
- Over-the-counter and prescriptions stimulants
- Decongestants
- Over-the-counter and prescription diet aids
- Antipsychotics
- Melatonin and all other drugs or supplements known to affect sleep/wake
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ramelteon 8 mg QD
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.
Secondary Outcome Measures
Mean Subjective Sleep Latency.
Mean Subjective Total Sleep
Mean Subjective Total Sleep
Adverse Events.
Clinical Laboratory Tests Hematology
Clinical Laboratory Tests Chemistry.
Clinical Laboratory Tests Urinalysis
Vital Signs.
Electrocardiograms.
Physical Examinations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00672724
Brief Title
Efficacy of Ramelteon in Adults With Chronic Insomnia
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective Response to Treatment With Ramelteon in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Issues with data collection tool
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.
Detailed Description
Insomnia is characterized by difficulties initiating and maintaining sleep, or complaints of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study is being conducted to assess the treatment effects of ramelteon in adults through the use of daily entry of information into an interactive voice response system. Study participation in this study is anticipated to be about 1 month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Insomnia, Sleep Disorder, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1081 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ramelteon 8 mg QD
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem™, TAK-375
Intervention Description
Ramelteon 8 mg tablets, taken orally, once daily for up to 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ramelteon placebo-matching tablets, taken orally, once daily for up to 2 weeks.
Primary Outcome Measure Information:
Title
Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Mean Subjective Sleep Latency.
Time Frame
Day 15
Title
Mean Subjective Total Sleep
Time Frame
Day 8
Title
Mean Subjective Total Sleep
Time Frame
Day 15
Title
Adverse Events.
Time Frame
Days 1, 8, and 15 or Final Visit.
Title
Clinical Laboratory Tests Hematology
Time Frame
Day 15 or Final Visit.
Title
Clinical Laboratory Tests Chemistry.
Time Frame
Day 15 or Final Visit.
Title
Clinical Laboratory Tests Urinalysis
Time Frame
Day 15 or Final Visit.
Title
Vital Signs.
Time Frame
Days 8 and 15 or Final Visit.
Title
Electrocardiograms.
Time Frame
Day 15 or Final Visit.
Title
Physical Examinations.
Time Frame
Day 15 or Final Visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Has had primary chronic insomnia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months.
Reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time less than 6.5 hours.
Habitual bedtime is between 10:00 PM and 1:00 AM.
Willing to have a fixed bedtime and agrees to go to bed within plus or minus 30 minutes of the habitual bedtime during the entire study.
Consistent access to a touch tone phone and are willing to complete telephone questionnaires twice daily during participation in the study.
Willing to remain in bed for at least 6.5 hours each night during the entire study.
Used pharmacological assistance to sleep 0-4 times per week in the last 3 months.
Must complete the morning questionnaire on at least 4 of the first 7 mornings after Screening Visit 1.
On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective sleep latency of greater than or equal to 45 minutes.
On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective total sleep time of less than 6.5 hours.
Exclusion Criteria
Known hypersensitivity to ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan.
Participated in any other investigational study and/or took any investigational drug within 30 days prior to the first dose of single-blind study medication.
Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication.
Has flown across greater than 3 time zones within 7 days prior to screening, or will travel across 2 or more time zones during the course of the study.
Participated in a weight loss program or has substantially altered exercise routine within 30 days prior to the first night of singleblind study medication.
Ever had a history of seizures, sleep apnea, and/or chronic obstructive pulmonary disease.
History of psychiatric disorder within the past 6 months.
History of fibromyalgia.
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, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
Uses tobacco products or any other products that may interfere with the sleep wake cycle during nightly awakenings.
Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
Positive hepatitis panel.
Any additional condition(s) that in the Investigator's opinion would:
affect sleep/wake function
prohibit the subject from completing the study
indicate that continuation in the study would not be in the best interests of the subject.
Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
Anxiolytics
Central nervous system active drugs
Hypnotics
Narcotic analgesics
Antidepressants
Beta blockers
Anticonvulsants
St. John's Wort
Sedating H1 antihistamines
Kava-kava
Systemic steroids
Ginkgo-biloba
Respiratory stimulants
Over-the-counter and prescriptions stimulants
Decongestants
Over-the-counter and prescription diet aids
Antipsychotics
Melatonin and all other drugs or supplements known to affect sleep/wake
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VP Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Mesa
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Scottsdale
State/Province
Arizona
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Cerritos
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Bay Harbor Island
State/Province
Florida
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Deland
State/Province
Florida
Country
United States
City
Fort Lauderdale
State/Province
Florida
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Hollywood
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Pinellas Park
State/Province
Florida
Country
United States
City
Vero Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Austell
State/Province
Georgia
Country
United States
City
Macon
State/Province
Georgia
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Northbrook
State/Province
Illinois
Country
United States
City
Prairie Village
State/Province
Kansas
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Frederick
State/Province
Maryland
Country
United States
City
Moorestown
State/Province
New Jersey
Country
United States
City
Menlius
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Salem
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Mogadore
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
12. IPD Sharing Statement
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Efficacy of Ramelteon in Adults With Chronic Insomnia
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