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InsomniaPhase 3NCT00656994

Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia

A Phase 3 study testing Ramelteon in people with Insomnia, run by Takeda at 29 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 effects of Ramelteon, once daily (QD), on endocrine function values. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
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
122 participants
Where
29 sitesUnited States
Study dates
Jan 2003to Jul 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 to 45 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 insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision for at least 3 months and a history of daytime complaint(s) associated with disturbed sleep.
  • Has a subjective sleep latency (sSL) greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours for at least 3 nights out of one week.
  • Habitual bedtime is between 8:30PM and 12:00AM.
  • Habitual awakening time is between 5:00 AM and 10:00 AM.
  • Male and female subjects must have serum prolactin, luteinizing hormone, follicle stimulating hormone, adrenocorticotropic hormone, thyroid stimulating hormone, triiodothyronine and thyroxine within normal range. Normal ranges for luteinizing hormone and follicle stimulating hormone for female subjects will be defined as the lowest value among the menstrual phases to the highest value among the menstrual phases.
Show all 9Show fewer
  • Body mass index between 18 and 34, inclusive.
  • Male subjects must have serum testosterone values of greater than or equal to 150 ng per dL.
  • Female subjects must have serum estradiol values within normal range.

Who cannot join

  • Known hypersensitivity to ramelteon or related compounds, including melatonin.
  • Previously participated in a study involving ramelteon.
  • Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
  • Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1, 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.
  • Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
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  • History of psychiatric disorder (including anxiety or depression) within the past 12 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, Text Revision and/or regularly consumes 4 or more alcoholic drinks per day.
  • Current significant neurological (including psychiatric and cognitive disorders), 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.
  • Uses tobacco products during nightly awakenings.
  • Used melatonin, or other drugs or supplements known to affect sleep/wake function within 1week (or 5 half lives of the drug, whichever is longer) prior to Day 1.
  • Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to Day 1. These medications must not have been used to treat psychiatric disorders.
  • 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 including anti- hepatitis A virus (only immunoglobulin M is exclusionary), anti- hepatitis B surface (except in subjects who have received hepatitis B virus vaccination), hepatitis B surface antigen, anti-hepatitis B core (only immunoglobulin M is exclusionary), or anti-hepatitis C virus..
  • Any significant endocrine pathology based on borderline laboratory results.
  • Any additional condition(s) that in the Investigator's opinion would:
  • affect endocrine function (eg, hyperthyroidism, diabetes)
  • 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 Screening visit of less than 7.0 μg per dl.
  • 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:
  • anxiolytics
  • hypnotics
  • antidepressants
  • anticonvulsants
  • sedating H1 antihistamines
  • systemic steroids
  • respiratory stimulants (eg, theophylline) and 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
  • other drugs or supplements known to affect sleep/wake function.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Study site

    Austell, Georgia

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    Florence, Kentucky

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Jasper, Alabama

  • Study site

    Kenilworth, New Jersey

  • Study site

    La Palma, California

  • Study site

    Los Angeles, California

  • Study site

    Mesa, Arizona

  • Study site

    Ninety Six, South Carolina

  • Study site

    Overland Park, Kansas

  • Study site

    Peoria, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Prairie Village, Kansas

  • Study site

    Riverside, California

  • Study site

    Roswell, Georgia

  • Study site

    San Angelo, Texas

  • Study site

    San Diego, California

  • Study site

    Sioux Falls, South Dakota

  • Study site

    South Plainfield, New Jersey

  • Study site

    Wentzville, Missouri

  • Study site

    West Palm Beach, Florida

  • Study site

    Wichita Falls, Texas

Other trials in United States

About this study

Official title: A Phase III Safety Study to Evaluate the Long-term Effects of TAK-375 on Endocrine Function in Adult Subjects With Chronic Insomnia

The purpose of this study is to determine the long-term effects of Ramelteon, once daily (QD), on endocrine function values.

Read the detailed description

Insomnia is characterized by a complaint of either difficulties initiating and maintaining sleep or of nonrestorative 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 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.

This study has been designed to determine the long-term (6 month) effects of Ramelteon on endocrine function values. Study participation is anticipated to be about 7 months.

Conditions
Insomnia
Being tested
Ramelteon, Placebo
Keywords
Sleep Disorder, Insomnia
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 16 mg, tablets, orally, once nightly for up to 6 months.

  • PlaceboDrug

    Ramelteon placebo-matching tablets, orally, once nightly for up to 6 months

Study groups in NCT00656994
Study groupRoleWhat they receive
Ramelteon 16 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. Change from baseline in Total Serum Thyroxine.

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

Secondary outcomes (13)

  1. Change from baseline in free thyroxine.

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  2. Change from baseline in thyroid stimulating hormone.

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  3. Change from baseline in triiodothyronine.

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  4. Change from baseline in total testosterone (men only).

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  5. Change from baseline in free testosterone (men only).

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  6. Change from baseline in estradiol (women only).

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  7. Change from baseline in prolactin.

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  8. Change from baseline in follicle stimulating hormone (women only).

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  9. Change from baseline in luteinizing hormone (women only).

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  10. Change from baseline in luteinizing hormone surge (women only)

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  11. Change from baseline in adrenocorticotropic hormone.

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  12. Change from baseline in cortisol (AM).

    Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit

  13. Change from baseline in adrenocorticotropic hormone stimulation test.

    Measured: Month 6 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 posted14 Apr 2008 (estimated)
  2. Study startJan 2003
  3. Primary completionJul 2004
  4. Study completionJul 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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00656994
Sponsor's protocol ID
01-02-TL-375-032
Other IDs
U1111-1114-2594
Status last verified
Feb 2012
First submitted
12 Mar 2008
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Richardson G, Wang-Weigand S. Effects of long-term exposure to ramelteon, a melatonin receptor agonist, on endocrine function in adults with chronic insomnia. Hum Psychopharmacol. 2009 Mar;24(2):103-11. doi: 10.1002/hup.993.

    PubMed 19090503

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon in people with Insomnia, run by Takeda at 29 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 9 inclusion and 39 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 29 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 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?

Change from baseline in Total Serum Thyroxine. (time frame: Months 1, 2, 3, 4, 5, and 6 or Final Visit). 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 NCT00656994, 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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