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Sleep Apnea, ObstructivePhase 2NCT00672061

Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea

A Phase 2 study of Sleep Apnea, Obstructive, run by Takeda at 5 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 assess the safety of ramelteon, once daily (QD), in individuals with obstructive sleep apnea. Read more about this study

Who is it for?
Ages 21 to 64 years
Conditions the study is for
Sleep Apnea, Obstructive
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
5 sitesUnited States
Study dates
Jul 2003to Dec 2003
Phase
Phase 2
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 21 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.
  • Clinical history of chronic obstructive pulmonary disease and a confirmatory diagnosis based on pulmonary function tests at screening.
  • Moderate: forced expiratory volume in one second/ forced vital capacity less than 70% and forced expiratory volume 135-75% of predicted.
  • Post-bronchodilator forced expiratory volume in one second change from baseline of less than 12%.
  • Negative chest x-ray at screening, other than findings consistent with mild to moderate chronic obstructive pulmonary disease, within the last 6 months.
  • Arterial oxygen saturation during sleep greater than 85% for at least 99% of the recording period, with no arterial oxygen saturation readings less than 80% as assessed by pulse oximetry at polysomnography screening.
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  • Arterial oxygen saturation during wakefulness greater than 91% (both supine and sitting) as assessed by pulse oximetry at screening.
  • Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
  • Body mass index between 18 and 34, inclusive.
  • Agrees to remain in the study center for three overnight stays.

Who cannot join

  • Known hypersensitivity to ramelteon or related compounds, including melatonin.
  • Known hypersensitivity to Ventolin® or related compounds.
  • 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 of study medication, whichever is longer.
  • Clinical history of acute or chronic respiratory failure, severe chronic obstructive pulmonary disease, or hypercapnia (Partial Pressure of Oxygen in Arterial Blood greater than or equal to45 mmHg).
  • History of or currently has right ventricular hypertrophy on electrocardiogram or right heart failure.
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  • Periodic leg movement with arousal index (per hour of sleep) greater than 20 as seen at polysomnography screening.
  • Apnea hypopnea index greater than 15 as seen at polysomnography screening.
  • Acute clinically significant illness within 2 weeks or has been hospitalized within 4 weeks of study participation.
  • Sleep schedule changes required by employment 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 medications.
  • History of seizures, sleep apnea, restless leg syndrome, period limb movement disorder, other known sleep disorders, schizophrenia, bipolar disease, mental retardation, or cognitive disorder.
  • History of psychiatric disorder 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 and/or regularly consumes 4 or more alcoholic drinks per day.
  • Unable to discontinue the use of hypnotics for the duration of the study.
  • Any clinically important abnormal finding, other than chronic obstructive pulmonary disease, as determined by medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
  • 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.
  • Hematocrit value greater than 55% at screening.
  • 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
  • not be in the best interest of the subject
  • 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
  • Decongestants
  • Over-the-counter and prescription stimulants
  • Over-the-counter and prescription diet aids
  • Central nervous system active drugs and narcotic analgesics
  • Lipophilic beta blockers
  • Melatonin
  • St. John's Wort
  • Kava-kava
  • Gingko biloba

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Study site

    Birmingham, Alabama

  • Study site

    Cincinnati, Ohio

  • Study site

    Palm Springs, California

  • Study site

    Santa Monica, California

  • Study site

    Winter Park, Florida

Other trials in United States

About this study

Official title: A Phase II Safety Study of TAK-375 in Subjects With Mild to Moderate Obstructive Sleep Apnea

The purpose of this study is to assess the safety of ramelteon, once daily (QD), in individuals with obstructive sleep apnea.

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 safety of Ramelteon in subjects with obstructive sleep apnea. Participation this this study is anticipated to be about 1.5 months.

Being tested
Ramelteon or Placebo
Keywords
Sleep Apnea, Obstructive, Insomnia, Drug Therapy
Medical subject headings
Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders

What participants receive

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

  • Ramelteon or PlaceboDrug

    Also called Rozerem, ramelteon, TAK-375

    Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2.

Study groups in NCT00672061
Study groupRoleWhat they receive
Ramelteon 16 mg QD or Placebo QDExperimentalNot described
Receives: Drug: Ramelteon or Placebo

What is being measured

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

  1. Apnea Hypopnea Index measured by Respiratory Inductance Plethysmography (RIP)

    Measured: Periods 1 and 2.

  2. Central Apnea Index.

    Measured: Periods 1 and 2.

  3. Mean Oxygen Saturation for the entire night.

    Measured: Periods 1 and 2.

  4. Obstructive Apnea Index.

    Measured: Periods 1 and 2.

  5. Hypopnea Index.

    Measured: Periods 1 and 2.

Secondary outcomes (22)

  1. Mean Oxygen Saturation for the entire night.

    Measured: Periods 1 and 2.

  2. Oxygen Saturation Means for Awake Sleep Stage.

    Measured: Periods 1 and 2.

  3. Oxygen Saturation Means for Non-Rapid Eye Movement Sleep Stage.

    Measured: Periods 1 and 2.

  4. Oxygen Saturation Means for Rapid Eye Movement Sleep Stage.

    Measured: Periods 1 and 2.

  5. Percentage of oxygen saturation is less than 80%.

    Measured: Periods 1 and 2.

  6. Latency to Persistent Sleep.

    Measured: Periods 1 and 2.

  7. Total Sleep Time.

    Measured: Periods 1 and 2.

  8. Sleep Efficiency.

    Measured: Periods 1 and 2.

  9. Awake Time after Persistent Sleep.

    Measured: Periods 1 and 2.

  10. Number of Awakenings after Persistent Sleep.

    Measured: Periods 1 and 2.

  11. Subjective Sleep Latency.

    Measured: Crossover Period 1 AM; Crossover Period 2 AM

  12. Subjective Total Sleep Time.

    Measured: Periods 1 and 2.

  13. Subjective Sleep Quality.

    Measured: Periods 1 and 2.

  14. Subjective Number of Awakenings.

    Measured: Periods 1 and 2.

  15. Subjective Ease of Falling Back to Sleep after Awakening.

    Measured: Periods 1 and 2.

  16. Subjective Level of Alertness.

    Measured: Periods 1 and 2.

  17. Subjective Ability to Concentrate.

    Measured: Periods 1 and 2.

  18. Percentage of Total Sleep Time in REM sleep

    Measured: Periods 1 and 2.

  19. Percentage of Total Sleep Time in Stage 1 NREM sleep

    Measured: Periods 1 and 2.

  20. Percentage of Total Sleep Time in Stage 2 NREM sleep

    Measured: Periods 1 and 2.

  21. Percentage of Total Sleep Time in Stage 3/4 NREM sleep

    Measured: Periods 1 and 2.

  22. Percentage of Total Sleep Time in latency to REM as determined by polysomnography

    Measured: Periods 1 and 2.

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 startJul 2003
  3. Primary completionDec 2003
  4. Study completionDec 2003

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672061
Sponsor's protocol ID
01-03-TL-375-039
Other IDs
U1111-1115-1494
Status last verified
Feb 2012
First submitted
2 May 2008
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Kryger M, Wang-Weigand S, Roth T. Safety of ramelteon in individuals with mild to moderate obstructive sleep apnea. Sleep Breath. 2007 Sep;11(3):159-64. doi: 10.1007/s11325-006-0096-4.

    PubMed 17294232

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Sleep Apnea, Obstructive, run by Takeda at 5 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 10 inclusion and 40 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Apnea Hypopnea Index measured by Respiratory Inductance Plethysmography (RIP) (time frame: Periods 1 and 2.). The study lists 5 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 NCT00672061, 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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