Efficacy of Ramelteon in Adults With Chronic Insomnia

February 27, 2012 updated by: Takeda

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

The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults with chronic insomnia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1081

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • Cerritos, California, United States
      • La Jolla, California, United States
      • La Mesa, California, United States
      • Oakland, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Bay Harbor Island, Florida, United States
      • Brandon, Florida, United States
      • Clearwater, Florida, United States
      • Deland, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Fort Myers, Florida, United States
      • Hollywood, Florida, United States
      • Miami, Florida, United States
      • Pembroke Pines, Florida, United States
      • Pinellas Park, Florida, United States
      • Vero Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Austell, Georgia, United States
      • Macon, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Northbrook, Illinois, United States
    • Kansas
      • Prairie Village, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maryland
      • Frederick, Maryland, United States
    • New Jersey
      • Moorestown, New Jersey, United States
    • New York
      • Menlius, New York, United States
      • New York, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Salem, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Mogadore, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States
    • Washington
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Ramelteon placebo-matching tablets, taken orally, once daily for up to 2 weeks.
Experimental: Ramelteon 8 mg QD
Drug: Ramelteon
Ramelteon 8 mg tablets, taken orally, once daily for up to 2 weeks.
Other Names:
  • TAK-375
  • Rozerem™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.
Time Frame: Day 8
Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Subjective Sleep Latency.
Time Frame: Day 15
Day 15
Mean Subjective Total Sleep
Time Frame: Day 8
Day 8
Mean Subjective Total Sleep
Time Frame: Day 15
Day 15
Adverse Events.
Time Frame: Days 1, 8, and 15 or Final Visit.
Days 1, 8, and 15 or Final Visit.
Clinical Laboratory Tests Hematology
Time Frame: Day 15 or Final Visit.
Day 15 or Final Visit.
Clinical Laboratory Tests Chemistry.
Time Frame: Day 15 or Final Visit.
Day 15 or Final Visit.
Clinical Laboratory Tests Urinalysis
Time Frame: Day 15 or Final Visit.
Day 15 or Final Visit.
Vital Signs.
Time Frame: Days 8 and 15 or Final Visit.
Days 8 and 15 or Final Visit.
Electrocardiograms.
Time Frame: Day 15 or Final Visit.
Day 15 or Final Visit.
Physical Examinations.
Time Frame: Day 15 or Final Visit.
Day 15 or Final Visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-04-TL-375-041
  • U1111-1114-2738 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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