Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease

NCT00316992 | Completed Phase 4

• 2 other identifiers: 01-05-TL-375-068U1111-1115-1960
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Insomnia; Chronic Obstructive Pulmonary Disease; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Mean oxygen saturation during sleep for the entire night measured by pulse oximetry.

  Crossover Period 1 Night 1 and Crossover Period 2 Night 1

Secondary Outcomes (20)

• Mean oxygen saturation calculated for each hour of the night, as measured by pulse oximetry.

  Crossover Period 1 Night 1 and Crossover Period 2 Night 1

• Mean oxygen saturation for rapid eye movement sleep stages, as measured by pulse oximetry.

  Crossover Period 1 Night 1 and Crossover Period 2 Night 1

• Mean oxygen saturation for non- rapid eye movement sleep stages, as measured by pulse oximetry.

  Crossover Period 1 Night 1 and Crossover Period 2 Night 1

• Minutes for which oxygen saturation was less than 80% as measured by pulse oximetry.

  Crossover Period 1 Night 1 and Crossover Period 2 Night 1

• Minutes for which oxygen saturation was less than 90% as measured by pulse oximetry.

  Crossover Period 1 Night 1 and Crossover Period 2 Night 1

Study Arms (1)

Ramelteon 8 mg and Placebo

EXPERIMENTAL

Drug: Ramelteon and Placebo

Interventions

Ramelteon and Placebo DRUG

Ramelteon 8 mg, tablets, orally, one night only and Ramelteon placebo-matching tablets, orally, one night only.

Also known as: Rozerem™, TAK-375

Ramelteon 8 mg and Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Body mass index between 18 and 34, inclusive.
• Clinical history of chronic obstructive pulmonary disease and a confirmatory diagnosis based on pulmonary function tests performed at the Outpatient Screening Visit, with moderate to severe airflow limitation defined by: Moderate: forced expiratory volume in one second to forced vital capacity less than 70%; 50% less than forced expiratory volume in one second; less than 80% predicted. Severe: forced expiratory volume in one second to forced vital capacity less than 70%; forced expiratory volume in one second less than 50% predicted.
• Post-bronchodilator forced expiratory volume in one second change from baseline of less than12% and not exceeding 200 ml at the Outpatient Screening Visit.
• Oxygen saturation during wakefulness greater than 90% (both supine and sitting) as assessed by pulse oximetry at the Outpatient Screening Visit.
• Oxygen saturation during sleep of greater than or equal to 80% for at least 75% of the recording period with no more than 5 continuous minutes less than 80% and with no oxygen saturation readings less than 70% as assessed by pulse oximetry at the Inpatient Screening Visit.

You may not qualify if:

• The health of subjects using nocturnal oxygen therapy would, in the investigator's opinion, be jeopardized by the removal of oxygen therapy during inpatient study visits.
• Electrocardiographic evidence of right ventricular hypertrophy, or evidence of right heart failure.
• Apnea hypopnea index (per hour of sleep) greater than 15 during polysomnography.
• Has had an acute clinically significant illness within two weeks or has been hospitalized within four weeks of the Outpatient Screening Visit.
• History of seizures (except childhood febrile seizures).
• History of cancer, other than basal cell carcinoma, that has not been in remission for at least five years prior to the first dose of study drug. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.)
• History of drug addiction or drug abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.
• History of alcohol abuse within the past 12 months, as defined in
• Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within six hours of any PSG visits.
• Will not refrain from use of tobacco products while in the sleep laboratory.
• 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 the Inpatient Screening Visit.
• Hematocrit value greater than 55% at the Outpatient Screening Visit.
• Alanine transaminase level of greater than three times the upper limit of normal, active liver disease, jaundice or any clinically significant abnormal laboratory findings as determined by the investigator.
• Donated more than 400 mL of blood within the 90 days preceding the beginning of the study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (8)

Unknown Facility

Birmingham, Alabama, 35213, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Naples, Florida, 34110, United States

Location

Unknown Facility

St. Petersburg, Florida, 33707, United States

Location

Unknown Facility

Louisville, Kentucky, 40217, United States

Location

Unknown Facility

Lincoln, Nebraska, 68510, United States

Location

Unknown Facility

New York, New York, 10025, United States

Location

Related Publications (1)

• Kryger M, Roth T, Wang-Weigand S, Zhang J. The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease. Sleep Breath. 2009 Mar;13(1):79-84. doi: 10.1007/s11325-008-0196-4. Epub 2008 Jun 27.

  PMID: 18584227 RESULT

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Medical Director Clinical Science

  Takeda Global Research and Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: April 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: June 2, 2010

Record last verified: 2010-05

Locations

US (8)