Chronic InsomniaPhase 3NCT00671294
Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.
A Phase 3 study of Chronic Insomnia, run by Takeda at 18 sites in United States.
Trial summary
This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia. Read more about this study
- Who is it for?
- Ages 65 years and older
- 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
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2002to Jul 2003
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or a post-menopausal female.
- Primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision for at least 3 months and as defined by subjective sleep latency greater than or equal to 30 minutes, subjective total sleep time less than or equal to 6.5 hours per night, and daytime complaint(s) associated with disturbed sleep.
- Mean latency of greater than or equal to 20 minutes per polysomnography on two consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
- Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
- Body mass index between 18 and 34, inclusive.
Who cannot join
- Known hypersensitivity to Ramelteon or related compounds, including melatonin.
- 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 single-blind study medication, whichever is longer.
- Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 of single-blind 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 single-blind study medication.
- Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
Show all 39Show fewer
- History of psychiatric disorder (including anxiety or depression) 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.
- Had an acute clinically significant illness, as determined by the investigator, within 30 days prior to Day 1 of single-blind study medication.
- Current significant neurological (including cognitive and psychiatric disorders), 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 single-blind study medication.
- Used tobacco products within 90 days prior to Day 1 of single-blind study medication.
- Used melatonin, or other drugs or supplements known to affect sleep/wake function, or has consumed grapefruit or grapefruit juice within 5 days (or 5 half lives, whichever is longer) prior to Day 1 of single-blind study medication.
- Used any central nervous system medication within 3 weeks (or 5 half lives of the drug, whichever is longer) prior to Day 1 of singleblind study medication. These medications must not have been used to treat psychiatric disorders.
- Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- Positive hepatitis panel including anti-hepatitis A virus (only immunoglobulin M is exclusionary), anti- hepatitis B surface (except in subjects who have received hepatitis B virus vaccination), hepatitis B surface antigen, anti- hepatitis B core (only immunoglobulin M is exclusionary), or anti-hepatitis C virus.
- Positive urine drug screen including alcohol at screening and each check-in or a positive breathalyzer test at each check-in.
- Apnea hypopnea index (per hour of sleep) greater than 15 as seen on polysonography, on the first night of the polysonography screening.
- Periodic leg movement with arousal index (per hour of sleep) greater than 20 as seen on polysonography, on the first night of polysonography screening.
- Any additional condition(s) that in the Investigator.s opinion would: a) affect sleep/wake function, b) prohibit the subject from completing the study, or c) not be in the best interest of the subject to participate in the study.
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Within 3 weeks prior to Day 1 of single-blind study medication and during the study:
- anxiolytics
- hypnotics
- antidepressants
- anticonvulsants
- sedating H1 antihistamines
- systemic steroids
- respiratory stimulants (eg, theophylline) and decongestants
- over-the counter and prescription stimulants
- over-the counter and prescription diet aids
- central nervous system active drugs (including herbal preparations with central nervous system effects)
- narcotic analgesics
- beta blockers
- St. John.s wort
- kava-kava
- gingko biloba, any other supplements
- Within 5 days prior to Day 1 of single-blind study medication and during the study:
- melatonin, or other drugs or supplements known to affect sleep/wake function.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Atlanta, Georgia
Study site
Brandon, Florida
Study site
Cincinnati, Ohio
Study site
Crestview Hills, Kentucky
Study site
Hot Springs, Arkansas
Study site
Houston, Texas
Study site
Irvine, California
Study site
Miami, Florida
Study site
Naples, Florida
Study site
Overland Park, Kansas
Study site
Palm Springs, California
Study site
Pembroke Pines, Florida
Study site
San Diego, California
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Toledo, Ohio
Study site
Troy, Michigan
Study site
Winston-Salem, North Carolina
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia.
This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.
Read the detailed description
Insomnia is characterized by a complaint of difficulties initiating and maintaining sleep or of nonrestorative 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 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.
Participation in this study is anticipated to be about 2 months.
- Conditions
- Chronic Insomnia
- Being tested
- Ramelteon and Placebo (9 possible combinations total)
- Keywords
- Insomnia
- 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 (9 possible combinations total)Drug
Also called Ramelteon, Rozerem, TAK-375
Randomized sequence over two consecutive nights for a total of three treatment periods to include the following:
Ramelteon 4 mg, tablets, orally over two nights
Ramelteon 8 mg, tablets, orally over two nights
Ramelteon placebo-matching tablets, orally over two nights
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon and Placebo QD (9 possible combinations total) | Experimental | Not described Receives: Drug: Ramelteon and Placebo (9 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 of 2-night per polysomnogram recordings, from nights 1 and 2 of each Treatment Period.
Measured: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Secondary outcomes (10)
Total Sleep Time.
Measured: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Sleep Efficiency.
Measured: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Wake Time after Sleep Onset.
Measured: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Number of Awakenings after Persistent Sleep Onset.
Measured: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Subjective Sleep Latency.
Measured: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Total Sleep Time.
Measured: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Wake Time after Sleep Onset.
Measured: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Number of Awakenings.
Measured: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Ease of Falling Back to Sleep after Awakening.
Measured: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Sleep Quality.
Measured: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 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 posted5 May 2008 (estimated)
- Study startOct 2002
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
- NCT00671294
- Sponsor's protocol ID
- 01-02-TL-375-017
- Other IDs
- U1111-1114-8272
- Status last verified
- Feb 2012
- First submitted
- 1 May 2008
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Roth T, Seiden D, Wang-Weigand S, Zhang J. A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia. Curr Med Res Opin. 2007 May;23(5):1005-14. doi: 10.1185/030079907x178874.
PubMed 17519067Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527.
PubMed 19327100
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 III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia.
- ClinicalTrials.gov ID
- NCT00671294
- Acronym / sponsor ID
- 01-02-TL-375-017
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 5 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 efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.
Detailed description
Insomnia is characterized by a complaint of difficulties initiating and maintaining sleep or of nonrestorative 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 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.
Participation in this study is anticipated to be about 2 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 and Placebo QD (9 possible combinations total) | Experimental | Drug: Ramelteon and Placebo (9 possible combinations total) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male or a post-menopausal female.
- Primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision for at least 3 months and as defined by subjective sleep latency greater than or equal to 30 minutes, subjective total sleep time less than or equal to 6.5 hours per night, and daytime complaint(s) associated with disturbed sleep.
- Mean latency of greater than or equal to 20 minutes per polysomnography on two consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
- Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
- Body mass index between 18 and 34, inclusive.
Key exclusion criteria (39 listed)
- Known hypersensitivity to Ramelteon or related compounds, including melatonin.
- 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 single-blind study medication, whichever is longer.
- Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 of single-blind 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 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 Placebo (9 possible combinations total)Also: Ramelteon, Rozerem, TAK-375Randomized sequence over two consecutive nights for a total of three treatment periods to include the following: Ramelteon 4 mg, tablets, orally over two nights Ramelteon 8 mg, tablets, orally over two nights Ramelteon placebo-matching tablets, orally over two nights | Drug | Ramelteon and Placebo QD (9 possible combinations total) |
Primary outcome
Mean latency to persistent sleep of 2-night per polysomnogram recordings, from nights 1 and 2 of each Treatment Period.
Time frame: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
10 secondary outcomes
Total Sleep Time.
Time frame: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Sleep Efficiency.
Time frame: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Wake Time after Sleep Onset.
Time frame: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Number of Awakenings after Persistent Sleep Onset.
Time frame: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.
Subjective Sleep Latency.
Time frame: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Total Sleep Time.
Time frame: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Wake Time after Sleep Onset.
Time frame: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Number of Awakenings.
Time frame: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Ease of Falling Back to Sleep after Awakening.
Time frame: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 or Final Visit.
Subjective Sleep Quality.
Time frame: Crossover Periods 1, 2, and 3 on Mornings 2 and 3 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.
- Results publication: PubMed 17519067Roth T, Seiden D, Wang-Weigand S, Zhang J. A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia. Curr Med Res Opin. 2007 May;23(5):1005-14. doi: 10.1185/030079907x178874.
- Results publication: PubMed 19327100Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527.
- Rozerem Package InsertLink 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.
VP Clinical Science study director
Takeda
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Chronic Insomnia, run by Takeda at 18 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 5 inclusion and 39 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 18 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 of 2-night per polysomnogram recordings, from nights 1 and 2 of each Treatment Period. (time frame: Crossover Periods 1, 2, and 3 on Nights 1 and 2 or Final Visit.). 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 NCT00671294, which also lists 2 linked publications.
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.