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Chronic InsomniaPhase 4NCT00414102

Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

A Phase 4 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Chronic Insomnia
What is being tested?
Ramelteon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
552 participants
Where
52 sitesUnited States
Study dates
Oct 2006to Sep 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
  • Body mass index between 18 and 34, inclusive.
  • Based on sleep history, has had chronic insomnia for at least 3 months.
  • Based on sleep history, reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time of less than or equal to 6.5 hours.
  • The difference of the average subjective sleep latency from days 1-3 to days 5-7 has to be less than or equal to 20 minutes during the single blind run-in period.
  • On at least 3 of the first 5 nights of single-blind run-in placebo treatment, the subject must have an subjective sleep latency of greater than or equal to 45 minutes and subjective total sleep time of less than or equal to 6.5 hours.
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  • Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
  • Willing to have a fixed bedtime and agrees to go to bed within 30 minutes of the habitual bedtime during the entire study.
  • Consistent access to a touch-tone phone and are willing to complete all paper and telephone questionnaires within 60 minutes of awakening each morning throughout the entire duration of the study.
  • Willing to remain in bed for at least 6.5 hours each night during the entire study.
  • Based on sleep history, uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.

Who cannot join

  • Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
  • Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
  • Has sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration 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.
  • Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
  • Has ever had a history of seizures; sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening polysomnography.
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  • History of psychiatric disorder within the past 6 months.
  • 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, or regularly consumes more than 14 alcoholic drinks per week, or for the inpatient subject consumed any alcoholic drinks within 24 hours of any polysomnography visits.
  • Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, neurological, 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 during nightly awakenings that may interfere with the sleep wake cycle.
  • Positive urine drug screen at initial screening Visit 2.
  • For inpatient subjects: has a positive breathalyzer test on any of the PSG assessment visits.
  • Exhibit a placebo response during single blinded placebo run in period.
  • Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
  • 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.
  • Positive hepatitis panel including hepatitis A virus- Immunoglobulin M, hepatitis-B surface antigen, hepatitis C virus antibody.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including the following:
  • Anxiolytics Antipsychotics
  • over-the-counter and Prescription Sedatives
  • 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 prescription diet aids
  • Sedating Decongestants
  • Muscle relaxants
  • Melatonin and all other drugs or supplements known to affect sleep/wake function.

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Auburn, Maine

  • Study site

    Austin, Texas

  • Study site

    Baltimore Area, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Boise, Idaho

  • Study site

    Charleston Area, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarkes Summitt, Pennsylvania

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Dallas, Texas

  • Study site

    Delray Beach, Florida

  • Study site

    Denver Area, Colorado

  • Study site

    Fort Myers, Florida

  • Study site

    Gallipolis, Ohio

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Honolulu, Hawaii

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Kansas City Area, Kansas

  • Study site

    Lexington, Kentucky

  • Study site

    Long Island City, New York

  • Study site

    Los Angeles Area, California

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Morganton, North Carolina

  • Study site

    Naples, Florida

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland Area, Oregon

  • Study site

    Rochester, New York

  • Study site

    Saint Louis Area, Missouri

  • Study site

    San Diego, California

  • Study site

    Seattle Area, Washington

  • Study site

    Spokane, Washington

  • Study site

    Staten Island, New York

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Washington D.C. Area, Maryland

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep Using a Post Sleep Questionnaire - Interactive Voice Response System (PSQ-IVRS) in an "At-Home Setting" in an Adult Population With Chronic Insomnia

The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia.

Read the detailed description

Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.

Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset under the brand name of Rozerem™.

This study will be comprised of two groups of subjects, 1) an outpatient group and 2) an inpatient group. The inpatient group will be used as reference arm as previously conducted studies in the sleep laboratory setting. Study participation is anticipated to be about 50 days (approximately 1.75 months).

Being tested
Ramelteon, Placebo
Keywords
Chronic Insomnia, Sleep Initiation and Maintenance Disorder, Drug Therapy
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamelteonDrug

    Also called TAK-375, Rozerem™

    Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.

  • PlaceboDrug

    Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.

Study groups in NCT00414102
Study groupRoleWhat they receive
Ramelteon 8 mg QDExperimentalNot described
Receives: Drug: Ramelteon
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average subjective Sleep Latency from Day 15 to Day 21

    Measured: Day 22

Secondary outcomes (6)

  1. Subjective Measures of Sleep Latency.

    Measured: Weeks 1 and 2 or Final Visit

  2. Subjective Total Sleep Time.

    Measured: Weeks 1, 2 and 3 or Final Visit

  3. Wake Time after Sleep Onset

    Measured: Weeks 1, 2 and 3 or Final Visit

  4. Number of Awakenings.

    Measured: Weeks 1, 2 and 3 or Final Visit

  5. Quality of Sleep.

    Measured: Weeks 1, 2 and 3 or Final Visit

  6. Rebound insomnia assessed from Nights 22 to 28 via self-reported sleep latency.

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00414102
Sponsor's protocol ID
01-05-TL-375-069
Other IDs
U1111-1115-2043
Status last verified
May 2010
First submitted
19 Dec 2006
Last updated
28 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average subjective Sleep Latency from Day 15 to Day 21 (time frame: Day 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00414102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.

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