Chronic Obstructive Pulmonary DiseasePhase 2NCT00672802
Safety of Ramelteon in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease
A Phase 2 study of Chronic Obstructive Pulmonary Disease and COPD, run by Takeda at 6 sites in United States.
Trial summary
This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2003to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 40Show fewer
- 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.
- Unable to discontinue the use of hypnotics for the duration of the study.
- 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 Day 1 of study medication.
- Hematocrit value greater than 55% at screening.
- Positive hepatitis panel.
- Any additional condition(s) that in the Investigator's opinion would:
- affect sleep-wake function
- prohibit the subject from completing the study
- not be in the best interest of the subject
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
- Anxiolytics
- Hypnotics
- Antidepressants
- Anticonvulsants
- Sedating H1 antihistamines
- Systemic steroids
- Decongestants
- Over-the-counter and prescription stimulants
- Over-the-counter and prescription diet aids
- Central nervous system active drugs and narcotic analgesics
- Lipophilic beta blockers
- Melatonin
- St. John's Wort
- Kava-kava
- Gingko biloba
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Birmingham, Alabama
Study site
Cincinnati, Ohio
Study site
Louisville, Kentucky
Study site
Miami Beach, Florida
Study site
Santa Monica, California
Study site
Winter Park, Florida
About this study
Official title: A Phase II Safety Study of TAK-375 in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease
This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects with chronic obstructive pulmonary disease.
Read the detailed description
Insomnia is characterized by difficulties initiating and maintaining sleep, or complaints of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study is being conducted to assess the safety of ramelteon in subjects with chronic obstructive pulmonary disease. Participation in the study is anticipated to be about 1.5 months.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- Ramelteon and Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Insomnia, Drug Therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramelteon and PlaceboDrug
Also called Rozerem™, ramelteon, TAK-375
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.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 16 mg QD and Placebo QD | Experimental | Not described Receives: Drug: Ramelteon and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Oxygen Saturation during sleep for the entire night.
Measured: Periods 1 and 2.
Secondary outcomes (20)
Mean Oxygen Saturation for each hour of the night.
Measured: Periods 1 and 2.
Mean Oxygen Saturation for awake Time Sleep Stage.
Measured: Periods 1 and 2.
Mean Oxygen Saturation for Nonrapid Eye Movement Sleep Stage.
Measured: Periods 1 and 2.
Mean Oxygen Saturation for Rapid Eye Movement Sleep Stage.
Measured: Periods 1 and 2.
Percentage of night when arterial oxygen percent saturation was less than 85%.
Measured: Periods 1 and 2.
Percentage of night when arterial oxygen percent saturation was less than 90%.
Measured: Periods 1 and 2.
Apnea Hypopnea Index measured by respiratory inductance plethysmography (RIP).
Measured: Periods 1 and 2.
Latency to Persistent Sleep.
Measured: Periods 1 and 2.
Total Sleep Time.
Measured: Periods 1 and 2.
Sleep Efficiency.
Measured: Periods 1 and 2.
Wake Time after Persistent Sleep Onset.
Measured: Periods 1 and 2.
Number of Awakenings after Persistent Sleep Onset.
Measured: Periods 1 and 2.
Subjective Sleep Latency.
Measured: Periods 1 and 2.
Subjective Total Sleep Time.
Measured: Periods 1 and 2.
Subjective Sleep Quality.
Measured: Periods 1 and 2.
Subjective Awake Time.
Measured: Periods 1 and 2.
Subjective Number of Awakenings.
Measured: Periods 1 and 2.
Subjective Ease of Falling Back to Sleep.
Measured: Periods 1 and 2.
Subjective Level of Alertness.
Measured: Periods 1 and 2.
Subjective Ability to Concentrate.
Measured: Periods 1 and 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startAug 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672802
- Sponsor's protocol ID
- 01-03-TL-375-038
- Other IDs
- U1111-1115-1343
- Status last verified
- Feb 2012
- First submitted
- 2 May 2008
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18060441
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety Study of TAK-375 in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00672802
- Acronym / sponsor ID
- 01-03-TL-375-038
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Insomnia, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects with chronic obstructive pulmonary disease.
Detailed description
Insomnia is characterized by difficulties initiating and maintaining sleep, or complaints of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.
Ramelteon is under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
This study is being conducted to assess the safety of ramelteon in subjects with chronic obstructive pulmonary disease. Participation in the study is anticipated to be about 1.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 16 mg QD and Placebo QD | Experimental | Drug: Ramelteon and Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (40 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramelteon and PlaceboAlso: Rozerem™, ramelteon, TAK-375Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2. | Drug | Ramelteon 16 mg QD and Placebo QD |
Primary outcome
Mean Oxygen Saturation during sleep for the entire night.
Time frame: Periods 1 and 2.
20 secondary outcomes
Mean Oxygen Saturation for each hour of the night.
Time frame: Periods 1 and 2.
Mean Oxygen Saturation for awake Time Sleep Stage.
Time frame: Periods 1 and 2.
Mean Oxygen Saturation for Nonrapid Eye Movement Sleep Stage.
Time frame: Periods 1 and 2.
Mean Oxygen Saturation for Rapid Eye Movement Sleep Stage.
Time frame: Periods 1 and 2.
Percentage of night when arterial oxygen percent saturation was less than 85%.
Time frame: Periods 1 and 2.
Percentage of night when arterial oxygen percent saturation was less than 90%.
Time frame: Periods 1 and 2.
Apnea Hypopnea Index measured by respiratory inductance plethysmography (RIP).
Time frame: Periods 1 and 2.
Latency to Persistent Sleep.
Time frame: Periods 1 and 2.
Total Sleep Time.
Time frame: Periods 1 and 2.
Sleep Efficiency.
Time frame: Periods 1 and 2.
Wake Time after Persistent Sleep Onset.
Time frame: Periods 1 and 2.
Number of Awakenings after Persistent Sleep Onset.
Time frame: Periods 1 and 2.
Subjective Sleep Latency.
Time frame: Periods 1 and 2.
Subjective Total Sleep Time.
Time frame: Periods 1 and 2.
Subjective Sleep Quality.
Time frame: Periods 1 and 2.
Subjective Awake Time.
Time frame: Periods 1 and 2.
Subjective Number of Awakenings.
Time frame: Periods 1 and 2.
Subjective Ease of Falling Back to Sleep.
Time frame: Periods 1 and 2.
Subjective Level of Alertness.
Time frame: Periods 1 and 2.
Subjective Ability to Concentrate.
Time frame: Periods 1 and 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Background: PubMed 18060441Kryger 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.
- Rozerem Package InsertLink provided by the sponsor.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VP Clinical Science study director
Takeda
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Chronic Obstructive Pulmonary Disease and COPD, run by Takeda at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Oxygen Saturation during sleep for the entire night. (time frame: Periods 1 and 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.