Back to resultsEfficacy and Safety of Ramelteon on Chronic Insomnia
Primary Purpose
Chronic Insomnia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ramelteon and Placebo (25 possible combinations total)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Sleep Initiation and Maintenance Disorders, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Has primary chronic insomnia for at least 3 months.
- Has a mean latency of greater than or equal to 20 minutes on 2 consecutive polysomnography screening nights with no night less than 15 minutes, and has a mean of at least 60 minutes of wake time across 2 nights with no night less than 45 minutes.
- Has a habitual bedtime between 8:30 PM and 12:00 AM.
- Has a body mass index that is not less than 17, but less than 34.
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion Criteria:
- Has a history of psychiatric disorder (including depression and anxiety), seizures, drug addiction, sleep apnea, nocturnal myoclonus and/or mental retardation as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
- Has a history of alcohol abuse within the previous 2 years.
- Has a hepatic disease, and a significant neurological, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease.
- Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
- Has a positive hepatitis panel including hepatitis A, hepatitis B or hepatitis C.
- Has any clinically abnormal findings as determined by a medical history, physical examination, electrocardiogram or clinical laboratory tests by the investigator or sub investigator.
- Has experienced 3 hours or more of jet lag within 7 days preceding the polysomnography screening.
- Has an apnea-hypopnea index (per hour of sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
- Has periodic limb movement with arousal index (per hour o sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
- Has participated in an excessive weight loss program that may have given influence on the evaluation of this study, or altered the participant's exercise routine within 30 days prior to double-blind study medication administration.
- Has had a clinically significant illness within 30 days prior to double-blind study medication administration.
- Has had sleep schedule changes required by employment (e.g., shift worker) within 3 months prior to double-blind study medication administration.
- The investigator or sub investigator judges the study subject inappropriate for participation because it is considered difficult to complete the study, or participating in the study will not be in the best interest of the subject.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ramelteon QD and Placebo QD (25 possible combinations total)
Arm Description
Outcomes
Primary Outcome Measures
Mean Latency to Persistent Sleep
Secondary Outcome Measures
Mean Total Sleep Time
Sleep Efficiency
Awake Time after Persistent Sleep
Percent of Total Sleep Time in NREM sleep Stage 1
Percent of Total Sleep Time in NREM sleep Stage 2
Percent of Total Sleep Time in NREM sleep Stage 3/4
Percent of Total Sleep Time in REM sleep Stage
Latency to REM sleep stage
Subjective Sleep Latency
Subjective Total Sleep Time
Subjective Sleep Quality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00915135
Brief Title
Efficacy and Safety of Ramelteon on Chronic Insomnia
Official Title
A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia
Detailed Description
Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Insomnia, Sleep Initiation and Maintenance Disorders, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ramelteon QD and Placebo QD (25 possible combinations total)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ramelteon and Placebo (25 possible combinations total)
Other Intervention Name(s)
Ramelteon, Rozerem, TAK-375
Intervention Description
Randomized sequence over two consecutive nights for a total of five treatment periods to include the following:
Ramelteon 4 mg, tablets, orally over two nights
Ramelteon 8 mg, tablets, orally over two nights
Ramelteon 16 mg, tablets, orally over two nights
Ramelteon 32 mg, tablets, orally over two nights
Ramelteon placebo-matching tablets, orally over two nights
Primary Outcome Measure Information:
Title
Mean Latency to Persistent Sleep
Time Frame
Mean of Nights 1 and 2.
Secondary Outcome Measure Information:
Title
Mean Total Sleep Time
Time Frame
Mean of Nights 1 and 2.
Title
Sleep Efficiency
Time Frame
Mean of Nights 1 and 2
Title
Awake Time after Persistent Sleep
Time Frame
Mean of Nights 1 and 2.
Title
Percent of Total Sleep Time in NREM sleep Stage 1
Time Frame
Mean of Nights 1 and 2.
Title
Percent of Total Sleep Time in NREM sleep Stage 2
Time Frame
Mean of Nights 1 and 2.
Title
Percent of Total Sleep Time in NREM sleep Stage 3/4
Time Frame
Mean of Nights 1 and 2.
Title
Percent of Total Sleep Time in REM sleep Stage
Time Frame
Mean of Nights 1 and 2.
Title
Latency to REM sleep stage
Time Frame
Mean of Nights 1 and 2.
Title
Subjective Sleep Latency
Time Frame
Mean of Nights 1 and 2.
Title
Subjective Total Sleep Time
Time Frame
Mean of Nights 1 and 2.
Title
Subjective Sleep Quality
Time Frame
Mean of Nights 1 and 2.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has primary chronic insomnia for at least 3 months.
Has a mean latency of greater than or equal to 20 minutes on 2 consecutive polysomnography screening nights with no night less than 15 minutes, and has a mean of at least 60 minutes of wake time across 2 nights with no night less than 45 minutes.
Has a habitual bedtime between 8:30 PM and 12:00 AM.
Has a body mass index that is not less than 17, but less than 34.
Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion Criteria:
Has a history of psychiatric disorder (including depression and anxiety), seizures, drug addiction, sleep apnea, nocturnal myoclonus and/or mental retardation as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
Has a history of alcohol abuse within the previous 2 years.
Has a hepatic disease, and a significant neurological, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease.
Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
Has a positive hepatitis panel including hepatitis A, hepatitis B or hepatitis C.
Has any clinically abnormal findings as determined by a medical history, physical examination, electrocardiogram or clinical laboratory tests by the investigator or sub investigator.
Has experienced 3 hours or more of jet lag within 7 days preceding the polysomnography screening.
Has an apnea-hypopnea index (per hour of sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
Has periodic limb movement with arousal index (per hour o sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
Has participated in an excessive weight loss program that may have given influence on the evaluation of this study, or altered the participant's exercise routine within 30 days prior to double-blind study medication administration.
Has had a clinically significant illness within 30 days prior to double-blind study medication administration.
Has had sleep schedule changes required by employment (e.g., shift worker) within 3 months prior to double-blind study medication administration.
The investigator or sub investigator judges the study subject inappropriate for participation because it is considered difficult to complete the study, or participating in the study will not be in the best interest of the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ramelteon on Chronic Insomnia
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