Chronic InsomniaPhase 2NCT00915135
Efficacy and Safety of Ramelteon on Chronic Insomnia
A Phase 2 study of Chronic Insomnia, run by Takeda.
Trial summary
The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Insomnia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Dec 2003
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has primary chronic insomnia for at least 3 months.
- Has a mean latency of greater than or equal to 20 minutes on 2 consecutive polysomnography screening nights with no night less than 15 minutes, and has a mean of at least 60 minutes of wake time across 2 nights with no night less than 45 minutes.
- Has a habitual bedtime between 8:30 PM and 12:00 AM.
- Has a body mass index that is not less than 17, but less than 34.
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Who cannot join
- Has a history of psychiatric disorder (including depression and anxiety), seizures, drug addiction, sleep apnea, nocturnal myoclonus and/or mental retardation as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
- Has a history of alcohol abuse within the previous 2 years.
- Has a hepatic disease, and a significant neurological, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease.
- Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
- Has a positive hepatitis panel including hepatitis A, hepatitis B or hepatitis C.
- Has any clinically abnormal findings as determined by a medical history, physical examination, electrocardiogram or clinical laboratory tests by the investigator or sub investigator.
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- Has experienced 3 hours or more of jet lag within 7 days preceding the polysomnography screening.
- Has an apnea-hypopnea index (per hour of sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
- Has periodic limb movement with arousal index (per hour o sleep) greater than or equal to 10 as seen on the first night of polysomnography screening.
- Has participated in an excessive weight loss program that may have given influence on the evaluation of this study, or altered the participant's exercise routine within 30 days prior to double-blind study medication administration.
- Has had a clinically significant illness within 30 days prior to double-blind study medication administration.
- Has had sleep schedule changes required by employment (e.g., shift worker) within 3 months prior to double-blind study medication administration.
- The investigator or sub investigator judges the study subject inappropriate for participation because it is considered difficult to complete the study, or participating in the study will not be in the best interest of the subject.
About this study
Official title: A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia
Read the detailed description
Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
- Conditions
- Chronic Insomnia
- Being tested
- Ramelteon and Placebo (25 possible combinations total)
- Keywords
- Insomnia, Sleep Initiation and Maintenance Disorders, Drug Therapy
- Medical subject headings
- 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 Placebo (25 possible combinations total)Drug
Also called Ramelteon, Rozerem, TAK-375
Randomized sequence over two consecutive nights for a total of five treatment periods to include the following:
Ramelteon 4 mg, tablets, orally over two nights
Ramelteon 8 mg, tablets, orally over two nights
Ramelteon 16 mg, tablets, orally over two nights
Ramelteon 32 mg, tablets, orally over two nights
Ramelteon placebo-matching tablets, orally over two nights
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon QD and Placebo QD (25 possible combinations total) | Experimental | Not described Receives: Drug: Ramelteon and Placebo (25 possible combinations total) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Latency to Persistent Sleep
Measured: Mean of Nights 1 and 2.
Secondary outcomes (11)
Mean Total Sleep Time
Measured: Mean of Nights 1 and 2.
Sleep Efficiency
Measured: Mean of Nights 1 and 2
Awake Time after Persistent Sleep
Measured: Mean of Nights 1 and 2.
Percent of Total Sleep Time in NREM sleep Stage 1
Measured: Mean of Nights 1 and 2.
Percent of Total Sleep Time in NREM sleep Stage 2
Measured: Mean of Nights 1 and 2.
Percent of Total Sleep Time in NREM sleep Stage 3/4
Measured: Mean of Nights 1 and 2.
Percent of Total Sleep Time in REM sleep Stage
Measured: Mean of Nights 1 and 2.
Latency to REM sleep stage
Measured: Mean of Nights 1 and 2.
Subjective Sleep Latency
Measured: Mean of Nights 1 and 2.
Subjective Total Sleep Time
Measured: Mean of Nights 1 and 2.
Subjective Sleep Quality
Measured: Mean of Nights 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 posted5 Jun 2009 (estimated)
- Study startMay 2002
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915135
- Sponsor's protocol ID
- TAK-375-CCT-001
- Other IDs
- U1111-1115-2062
- Status last verified
- May 2010
- First submitted
- 3 Jun 2009
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
- ClinicalTrials.gov ID
- NCT00915135
- Acronym / sponsor ID
- TAK-375-CCT-001
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia, Sleep Initiation and Maintenance Disorders, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 5 Jun 2009 (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.
The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia
Detailed description
Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
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 QD and Placebo QD (25 possible combinations total) | Experimental | Drug: Ramelteon and Placebo (25 possible combinations total) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has primary chronic insomnia for at least 3 months.
- Has a mean latency of greater than or equal to 20 minutes on 2 consecutive polysomnography screening nights with no night less than 15 minutes, and has a mean of at least 60 minutes of wake time across 2 nights with no night less than 45 minutes.
- Has a habitual bedtime between 8:30 PM and 12:00 AM.
- Has a body mass index that is not less than 17, but less than 34.
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Key exclusion criteria (13 listed)
- Has a history of psychiatric disorder (including depression and anxiety), seizures, drug addiction, sleep apnea, nocturnal myoclonus and/or mental retardation as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
- Has a history of alcohol abuse within the previous 2 years.
- Has a hepatic disease, and a significant neurological, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease.
- Has a known hypersensitivity to ramelteon or related compounds, including melatonin.
- Has a positive hepatitis panel including hepatitis A, hepatitis B or hepatitis C.
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 Placebo (25 possible combinations total)Also: Ramelteon, Rozerem, TAK-375Randomized sequence over two consecutive nights for a total of five treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon 16 mg, tablets, orally over two nights Ramelteon 32 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights | Drug | Ramelteon QD and Placebo QD (25 possible combinations total) |
Primary outcome
Mean Latency to Persistent Sleep
Time frame: Mean of Nights 1 and 2.
11 secondary outcomes
Mean Total Sleep Time
Time frame: Mean of Nights 1 and 2.
Sleep Efficiency
Time frame: Mean of Nights 1 and 2
Awake Time after Persistent Sleep
Time frame: Mean of Nights 1 and 2.
Percent of Total Sleep Time in NREM sleep Stage 1
Time frame: Mean of Nights 1 and 2.
Percent of Total Sleep Time in NREM sleep Stage 2
Time frame: Mean of Nights 1 and 2.
Percent of Total Sleep Time in NREM sleep Stage 3/4
Time frame: Mean of Nights 1 and 2.
Percent of Total Sleep Time in REM sleep Stage
Time frame: Mean of Nights 1 and 2.
Latency to REM sleep stage
Time frame: Mean of Nights 1 and 2.
Subjective Sleep Latency
Time frame: Mean of Nights 1 and 2.
Subjective Total Sleep Time
Time frame: Mean of Nights 1 and 2.
Subjective Sleep Quality
Time frame: Mean of Nights 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 2 Jun 2010.
- Rozerem Package Insert.Link provided by the sponsor.
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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.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Chronic Insomnia, run by Takeda.
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 5 inclusion and 13 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 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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 Latency to Persistent Sleep (time frame: Mean of Nights 1 and 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2010.