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Sleep Initiation and Maintenance DisordersPhase 3NCT00671086

Efficacy of Ramelteon in Subjects With Chronic Insomnia

A Phase 3 study testing Ramelteon in people with Sleep Initiation and Maintenance Disorders, run by Takeda at 122 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 long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ramelteon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,213 participants
Where
122 sitesUnited States
Study dates
Feb 2003to Sep 2004
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has participated in an allowed Ramelteon study and has completed all final visit procedures for the previous study within 21 days of the Treatment Initiation Visit for this study.
  • 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.
  • Investigator believes that participant requires long-term treatment for insomnia.
  • Primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep.
  • Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the Baseline Lead-in Period.
  • Habitual bedtime is between 8:30PM and 12:00AM.
  • Body mass index between 18 and 34, inclusive.

Who cannot join

  • Known hypersensitivity to Ramelteon or related compounds, including melatonin.
  • Participated in any other investigational study, and/or taken any investigational drug within 30 days or five half-lives prior to Day 1 of study medication, whichever is longer. The only exception to this is prior participation in an allowed Ramelteon study.
  • Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 of study medication, or has flown across greater than three time zones within seven days prior to screening.
  • Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to Day 1 of study medication.
  • Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
  • History of psychiatric disorder (including anxiety or depression) within the past 12 months.
Show all 35Show fewer
  • History of drug addiction or drug abuse with the past 12 months.
  • History of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
  • Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to Day 1 of study medication.
  • Uses tobacco products 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, or
  • not be in the best interest of the subject to participate in the study.
  • Morning serum cortisol at the Baseline visit of less than 7.0 micro-g per dl.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
  • Anxiolytics
  • Hypnotics
  • Antidepressants
  • Anticonvulsants
  • Sedating H1 antihistamines
  • Systemic steroids
  • Respiratory stimulants (eg, theophylline)
  • Decongestants
  • Over-the-counter and prescription stimulants
  • Over-the-counter and prescription diet aids
  • Central nervous system active drugs
  • Narcotic analgesics
  • Beta blockers
  • St. John's Wort
  • Kava-kava
  • Gingko biloba
  • Melatonin

Trial locations and contacts

122 sites in 1 country.

122 sites in 1 country

United States122 sites

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Austell, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bala-Cynwyd, Pennsylvania

  • Study site

    Baltimore, Maryland

  • Study site

    Beachwood, Ohio

  • Study site

    Billings, Montana

  • Study site

    Birmingham, Alabama

  • Study site

    Blairsville, Georgia

  • Study site

    Boise, Idaho

  • Study site

    Boulder, Colorado

  • Study site

    Brandon, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn, New York

  • Study site

    Bryan Pogue, Maryland

  • Study site

    Burbank, California

  • Study site

    Cary, North Carolina

  • Study site

    Cerritos, California

  • Study site

    Charlottesville, Virginia

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    City of Saint Peters, Missouri

  • Study site

    Clearwater, Florida

  • Study site

    Clementon, New Jersey

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Cordova, Tennessee

  • Study site

    DeLand, Florida

  • Study site

    Denver, Colorado

  • Study site

    Dublin, Ohio

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Edgewater, Florida

  • Study site

    Elk Grove Village, Illinois

  • Study site

    Eugene, Oregon

  • Study site

    Evansville, Indiana

  • Study site

    Fairfax, Virginia

  • Study site

    Florence, Kentucky

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Wayne, Indiana

  • Study site

    Frederick, Maryland

  • Study site

    Greer, South Carolina

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Irvine, California

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Kingston, New York

  • Study site

    La Jolla, California

  • Study site

    La Mesa, California

  • Study site

    Lafayette, California

  • Study site

    Lafayette Hill, Pennsylvania

  • Study site

    Lake Success, New York

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Lawrenceville, New Jersey

  • Study site

    Libertyville, Illinois

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    Macon, Georgia

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    Murrieta, California

  • Study site

    Naples, Florida

  • Study site

    New Orleans, Louisiana

  • Study site

    New Smyrna Beach, Florida

  • Study site

    Newark, New Jersey

  • Study site

    Newport Beach, California

  • Study site

    Newton, Massachusetts

  • Study site

    Northridge, California

  • Study site

    Oakland, Washington

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Paducah, Kentucky

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Plano, Texas

  • Study site

    Portland, Oregon

  • Study site

    Prince Frederick, Maryland

  • Study site

    Pueblo, Colorado

  • Study site

    Raleigh, North Carolina

  • Study site

    Redlands, California

  • Study site

    Riverside, California

  • Study site

    Rochester, New York

  • Study site

    Rockville, Maryland

  • Study site

    Safety Harbor, Florida

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Monica, California

  • Study site

    Seattle, Washington

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Shreveport, Louisiana

  • Study site

    Skokie, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stuart, Florida

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Toledo, Ohio

  • Study site

    Toma River, New Jersey

  • Study site

    Troy, Michigan

  • Study site

    Warwick, Rhode Island

  • Study site

    Wauwatosa, Wisconsin

  • Study site

    Wentzville, Missouri

  • Study site

    Wheat Ridge, Colorado

  • Study site

    White Plains, New York

  • Study site

    Williamsville, New York

  • Study site

    Wilmington, Delaware

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Park, Florida

Other trials in United States

About this study

Official title: A Phase 3, Open-label, Fixed-dose Study to Determine the Safety of Long-term Administration of TAK-375 in Subjects With Chronic Insomnia

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects 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 selective melatonin-1 receptor agonist 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.

The purpose of this study is to obtain data in support the safety of long-term use of Ramelteon for insomnia, and to determine whether there are any adverse effects associated with extended use. Participation in this study is expected to be about. Participation in this study is anticipated to be approximately 13 months.

Being tested
Ramelteon
Keywords
Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep, Insomnia Disorder Sleep Initiation Dysfunction, Transient Insomnia, Drug Therapy, Sleep Disorders, Intrinsic
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic

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

    Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.

  • RamelteonDrug

    Also called Rozerem, TAK-375

    Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.

Study groups in NCT00671086
Study groupRoleWhat they receive
Ramelteon 8 mg QDExperimentalNot described
Receives: Drug: Ramelteon
Ramelteon 16 mg QDExperimentalNot described
Receives: Drug: Ramelteon

What is being measured

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

  1. Adverse Events.

    Measured: Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.

  2. Change from Baseline in Vital Signs.

    Measured: Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit

  3. Change from Baseline in Hematology Laboratory Tests.

    Measured: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

  4. Change from Baseline in Chemistry Laboratory Tests.

    Measured: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

  5. Change from Baseline in Urinalysis Laboratory Tests.

    Measured: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

  6. Electrocardiograms.

    Measured: Month 6 and 12 or Final Visit.

  7. Menstrual Diary Results.

    Measured: Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

  8. Physical Examinations.

    Measured: Months 2, 4, 8, 10, and 12 or Final Visit.

Secondary outcomes (3)

  1. Change from Baseline in Subjective Total Sleep Time.

    Measured: Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.

  2. Change from Baseline in Subjective Sleep Latency.

    Measured: Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.

  3. Clinical Global Impression Scale.

    Measured: Months 6 and 12 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 posted5 May 2008 (estimated)
  2. Study startFeb 2003
  3. Primary completionSep 2004
  4. Study completionSep 2004

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00671086
Sponsor's protocol ID
01-02-TL-375-022
Other IDs
U1111-1114-3372
Status last verified
Feb 2012
First submitted
1 May 2008
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Richardson GS, Zammit G, Wang-Weigand S, Zhang J. Safety and subjective sleep effects of ramelteon administration in adults and older adults with chronic primary insomnia: a 1-year, open-label study. J Clin Psychiatry. 2009 Apr;70(4):467-76. doi: 10.4088/jcp.07m03834. Epub 2009 Mar 10.

    PubMed 19284927

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon in people with Sleep Initiation and Maintenance Disorders, run by Takeda at 122 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 7 inclusion and 35 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 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 122 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. 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 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?

Adverse Events. (time frame: Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.). The study lists 8 primary outcomes in all. 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 NCT00671086, which also lists 1 linked publication.

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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