NCT00672061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

May 2, 2008

Last Update Submit

February 27, 2012

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep Apnea, ObstructiveInsomniaDrug Therapy

Outcome Measures

Primary Outcomes (5)

  • Apnea Hypopnea Index measured by Respiratory Inductance Plethysmography (RIP)

    Periods 1 and 2.

  • Central Apnea Index.

    Periods 1 and 2.

  • Mean Oxygen Saturation for the entire night.

    Periods 1 and 2.

  • Obstructive Apnea Index.

    Periods 1 and 2.

  • Hypopnea Index.

    Periods 1 and 2.

Secondary Outcomes (22)

  • Mean Oxygen Saturation for the entire night.

    Periods 1 and 2.

  • Oxygen Saturation Means for Awake Sleep Stage.

    Periods 1 and 2.

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

    Periods 1 and 2.

  • Oxygen Saturation Means for Rapid Eye Movement Sleep Stage.

    Periods 1 and 2.

  • Percentage of oxygen saturation is less than 80%.

    Periods 1 and 2.

  • +17 more secondary outcomes

Study Arms (1)

Ramelteon 16 mg QD or Placebo QD

EXPERIMENTAL
Drug: Ramelteon or Placebo

Interventions

Ramelteon or PlaceboDRUG

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.

Also known as: Rozerem, ramelteon, TAK-375
Ramelteon 16 mg QD or Placebo QD

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Palm Springs, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Winter Park, Florida, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Related Publications (1)

  • 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.

    PMID: 17294232RESULT

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • VP Clinical Science

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 6, 2008

Study Start

July 1, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

US(5)