Safety of Ramelteon in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease

NCT00672802 | Completed Phase 2

• 2 other identifiers: 01-03-TL-375-038U1111-1115-1343
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

Brief Summary

This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects with chronic obstructive pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Insomnia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Mean Oxygen Saturation during sleep for the entire night.

  Periods 1 and 2.

Secondary Outcomes (20)

• Mean Oxygen Saturation for each hour of the night.

  Periods 1 and 2.

• Mean Oxygen Saturation for awake Time Sleep Stage.

  Periods 1 and 2.

• Mean Oxygen Saturation for Nonrapid Eye Movement Sleep Stage.

  Periods 1 and 2.

• Mean Oxygen Saturation for Rapid Eye Movement Sleep Stage.

  Periods 1 and 2.

• Percentage of night when arterial oxygen percent saturation was less than 85%.

  Periods 1 and 2.

Study Arms (1)

Ramelteon 16 mg QD and Placebo QD

EXPERIMENTAL

Drug: Ramelteon and Placebo

Interventions

Ramelteon and Placebo DRUG

Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2.

Also known as: Rozerem™, ramelteon, TAK-375

Ramelteon 16 mg QD and Placebo QD

Eligibility Criteria

• Age: 21 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (6)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Miami Beach, Florida, United States

Location

Unknown Facility

Winter Park, Florida, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Related Publications (1)

• 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. doi: 10.1007/s11325-007-0156-4.

  PMID: 18060441 BACKGROUND

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

• VP Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: August 1, 2003
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (6)