Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase II Safety Study of TAK-375 in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease
Verified date | February 2012 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects with chronic obstructive pulmonary disease.
Status | Completed |
Enrollment | 26 |
Est. completion date | March 2004 |
Est. primary completion date | March 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
United States,
Kryger M, Wang-Weigand S, Zhang J, Roth T. Effect of ramelteon, a selective MT(1)/MT (2)-receptor agonist, on respiration during sleep in mild to moderate COPD. Sleep Breath. 2008 Aug;12(3):243-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Oxygen Saturation during sleep for the entire night. | Periods 1 and 2. | Yes | |
Secondary | Mean Oxygen Saturation for each hour of the night. | Periods 1 and 2. | Yes | |
Secondary | Mean Oxygen Saturation for awake Time Sleep Stage. | Periods 1 and 2. | Yes | |
Secondary | Mean Oxygen Saturation for Nonrapid Eye Movement Sleep Stage. | Periods 1 and 2. | Yes | |
Secondary | Mean Oxygen Saturation for Rapid Eye Movement Sleep Stage. | Periods 1 and 2. | Yes | |
Secondary | Percentage of night when arterial oxygen percent saturation was less than 85%. | Periods 1 and 2. | Yes | |
Secondary | Percentage of night when arterial oxygen percent saturation was less than 90%. | Periods 1 and 2. | Yes | |
Secondary | Apnea Hypopnea Index measured by respiratory inductance plethysmography (RIP). | Periods 1 and 2. | Yes | |
Secondary | Latency to Persistent Sleep. | Periods 1 and 2. | No | |
Secondary | Total Sleep Time. | Periods 1 and 2. | No | |
Secondary | Sleep Efficiency. | Periods 1 and 2. | No | |
Secondary | Wake Time after Persistent Sleep Onset. | Periods 1 and 2. | No | |
Secondary | Number of Awakenings after Persistent Sleep Onset. | Periods 1 and 2. | No | |
Secondary | Subjective Sleep Latency. | Periods 1 and 2. | No | |
Secondary | Subjective Total Sleep Time. | Periods 1 and 2. | No | |
Secondary | Subjective Sleep Quality. | Periods 1 and 2. | No | |
Secondary | Subjective Awake Time. | Periods 1 and 2. | No | |
Secondary | Subjective Number of Awakenings. | Periods 1 and 2. | No | |
Secondary | Subjective Ease of Falling Back to Sleep. | Periods 1 and 2. | No | |
Secondary | Subjective Level of Alertness. | Periods 1 and 2. | No | |
Secondary | Subjective Ability to Concentrate. | Periods 1 and 2. | No |
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