Overview

Safety of Ramelteon in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease

Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
0
Participant gender:
All
Summary
This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects with chronic obstructive pulmonary disease.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Criteria
Inclusion Criteria

- 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.

Exclusion Criteria:

- 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.

- 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