Sleep Initiation and Maintenance DisordersPhase 2NCT00755495
Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia
A Phase 2 study testing Ramelteon and doxepin, Ramelteon and Doxepin in people with Sleep Initiation and Maintenance Disorders, run by Takeda.
Trial summary
The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), combined with doxepin in treating subjects with insomnia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Ramelteon and doxepin, Ramelteon and Doxepin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Mar 2007
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Based on sleep history, the subject has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised (DSM-IV-TR™) for at least 3 months.
- Female patients of childbearing potential must be nonpregnant and nonlactating, and utilizing an acceptable method of contraception.
- Has a body mass index between 18 and 34 inclusive (weight/height2).
- Based on sleep history, the subject reports subjective sleep latency greater than or equal to 45 minutes and reports wake time after persistent sleep onset of greater than or equal to 45 minutes.
- The subject has an average wake time after persistent sleep onset of at least 60 minutes as determined by polysomnography during Screening (Day -7 PM through Day -5 AM). Wake time after persistent sleep onset must be greater than or equal to 30 minutes each night of polysomnography Screening.
- In addition to meeting the criteria for wake time after persistent sleep onset, must have an average latency to persistent sleep of at least 20 minutes as determined by polysomnography during Screening (Day -7 PM through Day -5 AM). Latency to persistent sleep must be greater than or equal to 15 minutes each night of polysomnography Screening.
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- Based on sleep history, the subject's habitual bedtime is between 9:00 PM and 1:00 AM.
- Is willing to have a fixed bedtime and agrees to go to bed within +/-30 minutes of the habitual bedtime during the entire study.
- Is willing to remain in bed for at least 8 hours each night during the entire study.
- Based on sleep history, the subject either has not been using pharmacological assistance to sleep or uses pharmacological assistance no more than 4 times per week during the 3 months prior to Initial Screening. Subjects must agree to discontinue the use of all pharmacological sleep aids beginning 1 week prior to polysomnography Screening and throughout the entire duration of the study.
- Has consistent access to a touch-tone phone and are willing to complete telephone questionnaires during participation in the study.
Who cannot join
- Has a known hypersensitivity to doxepin or related compounds (tricyclic antidepressants), or ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan.
- Has participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of single-blind study medication.
- Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first dose of single-blind study medication.
- Has flown across greater than 3 time zones within 7 days prior to Initial Screening, or will travel across 2 or more time zones during the course of the study.
- Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first dose of single-blind study medication.
- Is required to take or intends to continue taking any disallowed medication or any prescription medication or over-the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication, including:
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- Anxiolytics central nervous system active drugs (including herbal).
- Hypnotics Narcotic analgesics.
- Antidepressants Beta blockers.
- Anticonvulsants St. John's Wort.
- Sedating H1 antihistamines Kava-kava.
- Systemic steroids Ginkgo-biloba.
- Respiratory stimulants over-the-counter and prescription stimulants.
- Sedating decongestants over-the-counter and prescription diet aids.
- Antipsychotics over-the-counter sleep aids.
- Muscle relaxants.
- Melatonin and all other drugs or supplements known to affect sleep/wake function.
- Has ever had a history of fibromyalgia, glaucoma, seizures (excluding childhood febrile seizures), sleep apnea, and/or chronic obstructive pulmonary disease.
- Currently has, or has had a diagnosed history of psychiatric disorder as defined in DSM-IV-TR™ (including anxiety, depression, suicidal ideation, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months of Initial Screening.
- Has a history of drug addiction or drug abuse as defined in DSM-IV-TR™ within the past 12 months of Initial Screening.
- Has a history of alcohol abuse within the past 12 months, as defined in DSM-IV-TR™ and/or regularly consumes more than 2 alcoholic drinks per day.
- Has a current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, metabolic or neurological disorders, or tendency for urinary retention, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first dose of single-blind study medication.
- Has a previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of single-blind study drug. (This criterion does not apply to subjects with basal cell or Stage 1 squamous cell carcinoma of the skin).
- Uses tobacco products or any other products that may interfere with the sleep wake cycle during nightly awakenings.
- Has used any central nervous system medication or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
- Has used melatonin, or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first dose of single-blind study medication.
- Has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- Has a positive hepatitis panel including anti- hepatitis A virus (only Immunoglobulin M [IgM] is exclusionary), hepatitis B surface antigen, or anti- hepatitis C virus.
- Has a history of human immuno-deficiency virus disease.
- Has a positive urine drug screen including alcohol at Initial Screening or a positive breathalyzer test at any polysomnography check-in.
- Has an apnea hypopnea index (per hour of sleep) >10 (subjects aged 18 to 64) or >15 (subjects aged 65 to 80) as seen on polysomnography, on the first night of the polysomnography screening.
- Has periodic leg movement with arousal index (per hour of sleep) >10 (subjects aged 18 to 64) or >15 (subjects aged 65 to 80) as seen on polysomnography, on the first night of polysomnography screening.
- Has a diastolic blood pressure greater than 90 mm Hg or a systolic pressure of greater than 150 mm Hg.
- The subject has an alanine transaminase level of greater than 3 times the upper limit of normal, active liver disease, or jaundice.
- Has 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.
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Proof-of-Concept Study to Evaluate the Safety and Efficacy of Ramelteon Taken in Combination With Doxepin for the Treatment of Subjects With Chronic Insomnia
The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), combined with doxepin in treating subjects with insomnia.
Read the detailed description
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is also associated with diminished work output, absenteeism, and greater rates of accidents. Gamma-aminobutyric acid is the major inhibitory transmitter in the central nervous system and most currently prescribed sleep agents are benzodiazepine receptor agonists, which induce sleep by binding to the benzodiazepine receptor site of the gamma-aminobutyric acid -A receptor complex. In addition to sleep, benzodiazepine receptor agonists can cause a wide range of ancillary effects not directly related to sleep, including sedative, anxiolytic, muscle-relaxant, and amnesic effects, and have risks of tolerance, dependence, and abuse potential.
Doxepin is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. Doxepin is indicated for the treatment of depression, anxiety, and psychotic depressive disorders. The most common adverse event associated with the use of doxepin is drowsiness. A limited number of controlled studies have been performed to examine the effects of low doxepin on insomnia.
TAK-375 (Ramelteon) is a melatonin receptor agonist with affinity for the human melatonin receptor subtype 1 (MT1), melatonin receptor subtype 2 (MT2) and selectivity over the melatonin receptor subtype 3 (MT3) receptor.
This trial will determine if the co-administration of ramelteon and doxepin will decrease both latency to persistent sleep and wake time after sleep onset. Study participation is anticipated to be about 2 months.
- Being tested
- Ramelteon and doxepin, Ramelteon, Doxepin, Placebo
- Keywords
- Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep, Insomnia Disorder Sleep Initiation Dysfunction, Transient Insomnia, Drug Therapy, Sleep Disorders, Intrinsic
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramelteon and doxepinDrug
Also called Rozerem™, TAK-375, Sinequan®, ramelteon
Ramelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.
RamelteonDrug
Also called Rozerem™, TAK-375
Ramelteon 8 mg, tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.
DoxepinDrug
Also called Sinequan®
Ramelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.
PlaceboDrug
Ramelteon placebo-matching tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg QD and Doxepin 3 mg QD | Experimental | Not described Receives: Drug: Ramelteon and doxepin |
| Ramelteon 8 mg QD and Doxepin Placebo QD | Experimental | Not described Receives: Drug: Ramelteon |
| Ramelteon Placebo QD and Doxepin 3 mg QD | Active comparator | Not described Receives: Drug: Doxepin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean wake time after persistent sleep onset during the double-blind Treatment Period, as measured by polysomnography
Measured: Weeks 1, 3, and 5 or Final Visit
Secondary outcomes (10)
Number of awakenings after persistent sleep determined by polysomnography.
Measured: Weeks 1, 3, and 5 or Final Visit
Latency to Persistent Sleep determined by polysomnography.
Measured: Weeks 1, 3, and 5 or Final Visit
Total Sleep Time determined by polysomnography.
Measured: Weeks 1, 3, and 5 or Final Visit
Subjective wake time after persistent sleep onset in the sleep lab and at home, as determined by post-sleep questionnaire completed by subject via IVRS.
Measured: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective number of awakenings in the sleep lab and at home, as determined by post-sleep questionnaire completed by subject via IVRS.
Measured: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective sleep latency using a postsleep questionnaire collected via IVRS.
Measured: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective total sleep time using a postsleep questionnaire collected via IVRS.
Measured: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective sleep quality using a postsleep questionnaire collected via IVRS.
Measured: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Latency to rapid eye movement sleep determined by polysomnography.
Measured: Weeks 1, 3, and 5 or Final Visit
Sleep efficiency per polysomnography.
Measured: Weeks 1, 3, and 5 or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startJul 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755495
- Sponsor's protocol ID
- 01-05-TL-375-067
- Other IDs
- U1111-1114-2536
- Status last verified
- Feb 2012
- First submitted
- 17 Sep 2008
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
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 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Proof-of-Concept Study to Evaluate the Safety and Efficacy of Ramelteon Taken in Combination With Doxepin for the Treatment of Subjects With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT00755495
- Acronym / sponsor ID
- 01-05-TL-375-067
- Keywords
- Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep, Insomnia Disorder Sleep Initiation Dysfunction, Transient Insomnia, Drug Therapy, Sleep Disorders, Intrinsic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 19 Sep 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.
The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), combined with doxepin in treating subjects with insomnia.
Detailed description
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is also associated with diminished work output, absenteeism, and greater rates of accidents. Gamma-aminobutyric acid is the major inhibitory transmitter in the central nervous system and most currently prescribed sleep agents are benzodiazepine receptor agonists, which induce sleep by binding to the benzodiazepine receptor site of the gamma-aminobutyric acid -A receptor complex. In addition to sleep, benzodiazepine receptor agonists can cause a wide range of ancillary effects not directly related to sleep, including sedative, anxiolytic, muscle-relaxant, and amnesic effects, and have risks of tolerance, dependence, and abuse potential.
Doxepin is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. Doxepin is indicated for the treatment of depression, anxiety, and psychotic depressive disorders. The most common adverse event associated with the use of doxepin is drowsiness. A limited number of controlled studies have been performed to examine the effects of low doxepin on insomnia.
TAK-375 (Ramelteon) is a melatonin receptor agonist with affinity for the human melatonin receptor subtype 1 (MT1), melatonin receptor subtype 2 (MT2) and selectivity over the melatonin receptor subtype 3 (MT3) receptor.
This trial will determine if the co-administration of ramelteon and doxepin will decrease both latency to persistent sleep and wake time after sleep onset. Study participation is anticipated to be about 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg QD and Doxepin 3 mg QD | Experimental | Drug: Ramelteon and doxepin |
| Ramelteon 8 mg QD and Doxepin Placebo QD | Experimental | Drug: Ramelteon |
| Ramelteon Placebo QD and Doxepin 3 mg QD | Active comparator | Drug: Doxepin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Based on sleep history, the subject has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised (DSM-IV-TR™) for at least 3 months.
- Female patients of childbearing potential must be nonpregnant and nonlactating, and utilizing an acceptable method of contraception.
- Has a body mass index between 18 and 34 inclusive (weight/height2).
- Based on sleep history, the subject reports subjective sleep latency greater than or equal to 45 minutes and reports wake time after persistent sleep onset of greater than or equal to 45 minutes.
- The subject has an average wake time after persistent sleep onset of at least 60 minutes as determined by polysomnography during Screening (Day -7 PM through Day -5 AM). Wake time after persistent sleep onset must be greater than or equal to 30 minutes each night of polysomnography Screening.
Key exclusion criteria (38 listed)
- Has a known hypersensitivity to doxepin or related compounds (tricyclic antidepressants), or ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan.
- Has participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of single-blind study medication.
- Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first dose of single-blind study medication.
- Has flown across greater than 3 time zones within 7 days prior to Initial Screening, or will travel across 2 or more time zones during the course of the study.
- Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first dose of single-blind study medication.
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 doxepinAlso: Rozerem™, TAK-375, Sinequan®, ramelteonRamelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks. | Drug | Ramelteon 8 mg QD and Doxepin 3 mg QD |
| RamelteonAlso: Rozerem™, TAK-375Ramelteon 8 mg, tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks. | Drug | Ramelteon 8 mg QD and Doxepin Placebo QD |
| DoxepinAlso: Sinequan®Ramelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks. | Drug | Ramelteon Placebo QD and Doxepin 3 mg QD |
| PlaceboRamelteon placebo-matching tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks. | Drug | Placebo |
Primary outcome
Mean wake time after persistent sleep onset during the double-blind Treatment Period, as measured by polysomnography
Time frame: Weeks 1, 3, and 5 or Final Visit
10 secondary outcomes
Number of awakenings after persistent sleep determined by polysomnography.
Time frame: Weeks 1, 3, and 5 or Final Visit
Latency to Persistent Sleep determined by polysomnography.
Time frame: Weeks 1, 3, and 5 or Final Visit
Total Sleep Time determined by polysomnography.
Time frame: Weeks 1, 3, and 5 or Final Visit
Subjective wake time after persistent sleep onset in the sleep lab and at home, as determined by post-sleep questionnaire completed by subject via IVRS.
Time frame: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective number of awakenings in the sleep lab and at home, as determined by post-sleep questionnaire completed by subject via IVRS.
Time frame: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective sleep latency using a postsleep questionnaire collected via IVRS.
Time frame: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective total sleep time using a postsleep questionnaire collected via IVRS.
Time frame: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Subjective sleep quality using a postsleep questionnaire collected via IVRS.
Time frame: Weeks 1, 2, 3, 4, and 5 or Final Visit.
Latency to rapid eye movement sleep determined by polysomnography.
Time frame: Weeks 1, 3, and 5 or Final Visit
Sleep efficiency per polysomnography.
Time frame: Weeks 1, 3, and 5 or Final Visit
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.
- 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 Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramelteon and doxepin, Ramelteon and Doxepin in people with Sleep Initiation and Maintenance Disorders, 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 11 inclusion and 38 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 wake time after persistent sleep onset during the double-blind Treatment Period, as measured by polysomnography (time frame: Weeks 1, 3, and 5 or Final Visit). 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 28 Feb 2012.