A Study of the Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Ramelteon (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Sherry Weigand, MD, PhD, Study Director, Affiliation: Takeda Global Research and Development
Summary
This study will evaluate the safety of ramelteon, a newly approved insomnia medication, in
patients with chronic obstructive pulmonary disease (COPD). Patients will complete five
study visits, three of which will require overnight stays in the sleep clinic.
Clinical Details
Official title: A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: To determine whether ramelteon has respiratory depressant effects in subjects with moderate to severe Chronic Obstructive Pulmonary Disease.
Secondary outcome: To evaluate the safety and tolerability of ramelteon in subjects with moderate to severe Chronic Obstructive Pulmonary Disease.To evaluate the effects of ramelteon on sleep by means of subjective and objective assessments.
Detailed description:
This is a randomized, double-blind, crossover, placebo controlled study in subjects with
moderate to severe chronic obstructive pulmonary disease (COPD). Randomized subjects will
receive one dose each of ramelteon and matching placebo in the crossover design. A 5 to 10
day washout will occur between doses. One follow up visit will be completed approximately one
week after the final treatment period.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject is 40 years of age or older, with moderate to severe chronic obstructive
pulmonary disease.
- The subject has a habitual bedtime between 9 pm and 1 am, inclusive.
Exclusion Criteria:
- The subject has a known hypersensitivity to ramelteon or related compounds, including
melatonin or albuterol or related compounds.
- The subject has electrocardiographic evidence of right ventricular hypertrophy, or
evidence of right heart failure.
- The subject requires nocturnal oxygen therapy.
- The subject has had a history of seizures, sleep apnea, restless leg syndrome,
periodic limb movement disorder, other known sleep disorders (except insomnia),
fibromyalgia, schizophrenia, bipolar disease, mental retardation, or cognitive
disorder.
- The subject has been treated for a psychiatric disorder (including anxiety or
depression) within the past six months.
- The subject is unable to discontinue the use of hypnotics for the duration of the
study.
Locations and Contacts
Birmingham, Alabama 35213, United States
Los Angeles, California, United States
Santa Monica, California 90404, United States
Naples, Florida 34110, United States
St. Petersburg, Florida 33707, United States
Louisville, Kentucky 40217, United States
Lincoln, Nebraska 68510, United States
New York, New York 10025, United States
Additional Information
Starting date: March 2006
Ending date: November 2006
Last updated: June 10, 2008
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