A Study of the Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00316992

Purpose

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
Chronic Obstructive Pulmonary Disease	Drug: Ramelteon Drug: Placebo	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Ramelteon

U.S. FDA Resources

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

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

To determine whether ramelteon has respiratory depressant effects in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of ramelteon in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
To evaluate the effects of ramelteon on sleep by means of subjective and objective assessments. [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

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
1 Ramelteon & Placebo	Drug: Ramelteon 8 mg Ramelteon tablet, orally, one night only. Drug: Placebo Placebo tablet, orally, one night only.

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316992

Locations

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

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Sherry Weigand, MD, PhD

Takeda Global Research and Development

More Information

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

Keywords provided by Takeda Global Research & Development Center, Inc.:

Insomnia
Chronic Obstructive Pulmonary Disease
Drug Therapy

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009