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Chronic InsomniaPhase 3NCT00672724

Efficacy of Ramelteon in Adults With Chronic Insomnia

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 43 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), 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
1,081 participants
Where
43 sitesUnited States
Study dates
Feb 2005to Aug 2005
Phase
Phase 3
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.
  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Austell, Georgia

  • Study site

    Bay Harbor Island, Florida

  • Study site

    Boise, Idaho

  • Study site

    Brandon, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Cerritos, California

  • Study site

    Chattanooga, Tennessee

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Dallas, Texas

  • Study site

    DeLand, Florida

  • Study site

    Denver, Colorado

  • Study site

    Fairfax, Virginia

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Frederick, Maryland

  • Study site

    Hollywood, Florida

  • Study site

    Hot Springs, Arkansas

  • Study site

    La Jolla, California

  • Study site

    La Mesa, California

  • Study site

    Louisville, Kentucky

  • Study site

    Macon, Georgia

  • Study site

    Menlius, New York

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Mogadore, Ohio

  • Study site

    Moorestown, New Jersey

  • Study site

    New York, New York

  • Study site

    Northbrook, Illinois

  • Study site

    Oakland, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pinellas Park, Florida

  • Study site

    Prairie Village, Kansas

  • Study site

    Salem, North Carolina

  • Study site

    Scottsdale, Arizona

  • Study site

    Tacoma, Washington

  • Study site

    Vero Beach, Florida

  • Study site

    Wichita, Kansas

  • Study site

    Williamsville, New York

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: 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.

Read the 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.

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

What participants receive

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

  • RamelteonDrug

    Also called Rozerem™, TAK-375

    Ramelteon 8 mg tablets, taken orally, once daily for up to 2 weeks.

  • PlaceboDrug

    Ramelteon placebo-matching tablets, taken orally, once daily for up to 2 weeks.

Study groups in NCT00672724
Study groupRoleWhat they receive
Ramelteon 8 mg QDExperimentalNot described
Receives: Drug: Ramelteon
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.

    Measured: Day 8

Secondary outcomes (10)

  1. Mean Subjective Sleep Latency.

    Measured: Day 15

  2. Mean Subjective Total Sleep

    Measured: Day 8

  3. Mean Subjective Total Sleep

    Measured: Day 15

  4. Adverse Events.

    Measured: Days 1, 8, and 15 or Final Visit.

  5. Clinical Laboratory Tests Hematology

    Measured: Day 15 or Final Visit.

  6. Clinical Laboratory Tests Chemistry.

    Measured: Day 15 or Final Visit.

  7. Clinical Laboratory Tests Urinalysis

    Measured: Day 15 or Final Visit.

  8. Vital Signs.

    Measured: Days 8 and 15 or Final Visit.

  9. Electrocardiograms.

    Measured: Day 15 or Final Visit.

  10. Physical Examinations.

    Measured: Day 15 or Final Visit.

Timeline

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

  1. First posted6 May 2008 (estimated)
  2. Study startFeb 2005
  3. Primary completionAug 2005
  4. Study completionAug 2005

Why it stopped: Issues with data collection tool

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,081 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672724
Sponsor's protocol ID
01-04-TL-375-041
Other IDs
U1111-1114-2738
Status last verified
Feb 2012
First submitted
2 May 2008
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 43 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 37 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: stopped early, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Issues with data collection tool). Results are not available in the source record.

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?

Mean Subjective Sleep Latency determined through subject responses on morning questionnaire. (time frame: Day 8). 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 NCT00672724.

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 Feb 2012.

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