Efficacy and Safety of Ramelteon on Chronic Insomnia

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00915135
First received: June 3, 2009
Last updated: May 31, 2010
Last verified: May 2010
  Purpose

The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia


Condition Intervention Phase
Chronic Insomnia
Drug: Ramelteon and Placebo (25 possible combinations total)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Mean Latency to Persistent Sleep [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Total Sleep Time [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Sleep Efficiency [ Time Frame: Mean of Nights 1 and 2 ] [ Designated as safety issue: No ]
  • Awake Time after Persistent Sleep [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Percent of Total Sleep Time in NREM sleep Stage 1 [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Percent of Total Sleep Time in NREM sleep Stage 2 [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Percent of Total Sleep Time in NREM sleep Stage 3/4 [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Percent of Total Sleep Time in REM sleep Stage [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Latency to REM sleep stage [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Subjective Sleep Latency [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Subjective Total Sleep Time [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]
  • Subjective Sleep Quality [ Time Frame: Mean of Nights 1 and 2. ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: May 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramelteon QD and Placebo QD (25 possible combinations total) 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915135

Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
No publications provided

Responsible Party: General Manager, Japan Development Center, Pharmaceutical Development Division
ClinicalTrials.gov Identifier: NCT00915135     History of Changes
Other Study ID Numbers: TAK-375-CCT-001, U1111-1115-2062
Study First Received: June 3, 2009
Last Updated: May 31, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Takeda:
Insomnia
Sleep Initiation and Maintenance Disorders
Drug Therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014