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Efficacy and Safety of Ramelteon on Chronic Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00915135
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
Takeda

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 5, 2009
Last Update Posted Date June 2, 2010
Study Start Date  ICMJE May 2002
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Mean Latency to Persistent Sleep [ Time Frame: Mean of Nights 1 and 2. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
  • Mean Total Sleep Time [ Time Frame: Mean of Nights 1 and 2. ]
  • Sleep Efficiency [ Time Frame: Mean of Nights 1 and 2 ]
  • Awake Time after Persistent Sleep [ Time Frame: Mean of Nights 1 and 2. ]
  • Percent of Total Sleep Time in NREM sleep Stage 1 [ Time Frame: Mean of Nights 1 and 2. ]
  • Percent of Total Sleep Time in NREM sleep Stage 2 [ Time Frame: Mean of Nights 1 and 2. ]
  • Percent of Total Sleep Time in NREM sleep Stage 3/4 [ Time Frame: Mean of Nights 1 and 2. ]
  • Percent of Total Sleep Time in REM sleep Stage [ Time Frame: Mean of Nights 1 and 2. ]
  • Latency to REM sleep stage [ Time Frame: Mean of Nights 1 and 2. ]
  • Subjective Sleep Latency [ Time Frame: Mean of Nights 1 and 2. ]
  • Subjective Total Sleep Time [ Time Frame: Mean of Nights 1 and 2. ]
  • Subjective Sleep Quality [ Time Frame: Mean of Nights 1 and 2. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Ramelteon on Chronic Insomnia
Official Title  ICMJE A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Insomnia
Intervention  ICMJE Drug: Ramelteon and Placebo (25 possible combinations total)

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

Other Names:
  • Ramelteon
  • Rozerem
  • TAK-375
Study Arms  ICMJE Experimental: Ramelteon QD and Placebo QD (25 possible combinations total)
Intervention: Drug: Ramelteon and Placebo (25 possible combinations total)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2003
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00915135
Other Study ID Numbers  ICMJE TAK-375-CCT-001
U1111-1115-2062 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party General Manager, Japan Development Center, Pharmaceutical Development Division
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP