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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00316992 |
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.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease |
Drug: Ramelteon Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease |
Enrollment: | 25 |
Study Start Date: | March 2006 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Ramelteon & Placebo
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Drug: Ramelteon
8 mg Ramelteon tablet, orally, one night only.
Drug: Placebo
Placebo tablet, orally, one night only.
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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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Birmingham, Alabama, United States, 35213 | |
United States, California | |
Los Angeles, California, United States | |
Santa Monica, California, United States, 90404 | |
United States, Florida | |
Naples, Florida, United States, 34110 | |
St. Petersburg, Florida, United States, 33707 | |
United States, Kentucky | |
Louisville, Kentucky, United States, 40217 | |
United States, Nebraska | |
Lincoln, Nebraska, United States, 68510 | |
United States, New York | |
New York, New York, United States, 10025 |
Study Director: | Sherry Weigand, MD, PhD | Takeda Global Research and Development |
Responsible Party: | Takeda Global Research & Development, Inc. ( VP, Clinical Science ) |
Study ID Numbers: | 01-05-TL-375-068 |
Study First Received: | April 19, 2006 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00316992 |
Health Authority: | United States: Food and Drug Administration |
Insomnia Chronic Obstructive Pulmonary Disease Drug Therapy |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |