Transient InsomniaPhase 3NCT00671398
Efficacy of Ramelteon on Transient Insomnia in Healthy Adults
A Phase 3 study testing Ramelteon in people with Transient Insomnia, run by Takeda at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Transient Insomnia
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2002to May 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- 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.
- Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
- Sleeps 6.5 to 8 hours per night and has a subjective sleep latency of less than or equal to 30 minutes.
- Body mass index between 18 and 34, inclusive.
Who cannot join
- Any history of insomnia.
- Spent one or more nights in a sleep laboratory.
- Epworth Sleepiness Scale score of greater than 10.
- 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, whichever is longer.
Show all 39Show fewer
- Sleep schedule changes required by employment (ie, shift work) within three months preceding Day 1 or has flown across greater than three time zones within seven days prior to screening.
- Participated in a weight loss program or substantially altered their exercise routine within 30 days prior to Day 1.
- History of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- History of a psychiatric disorder (including anxiety or depression) within the past 12 months.
- History of drug addiction or drug abuse within the past 12 months.
- Any physical or psychiatric disorder that may be associated with sleep disturbance.
- History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes 4 or more alcoholic drinks per day.
- Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic or metabolic disease.
- Uses tobacco products during nightly awakenings.
- 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.
- Positive urine drug screen including alcohol at screening or a positive breathalyzer test at check-in.
- 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
- Respiratory stimulants (eg, theophylline)
- Decongestants
- Over-the-counter and prescription stimulants
- Over-the-counter and prescription diet aids
- Central nervous system active drugs
- Narcotic analgesics
- All beta blockers
- St. John's Wort
- Kava-kava
- gingko biloba
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Atlanta, Georgia
Study site
Cincinnati, Ohio
Study site
Columbia, South Carolina
Study site
Dublin, Ohio
Study site
Houston, Texas
Study site
Miami, Florida
Study site
New York, New York
Study site
Overland Park, Kansas
Study site
Palm Springs, California
Study site
Pembroke Pines, Florida
Study site
Rochester, New York
Study site
San Diego, California
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.
Read the detailed description
Insomnia is characterized by difficulties initiating and maintaining sleep, or 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 a selective melatonin-1 receptor agonist 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 evaluate the safety and efficacy of a single dose of Ramelteon in normal healthy subjects in a sleep lab model of transient insomnia. Participation is this study is anticipated to be about 3 weeks.
- Conditions
- Transient Insomnia
- Being tested
- Ramelteon, Placebo
- Keywords
- Insomnia, Sleep Disorder, Drug Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem™, TAK-375
Ramelteon 8 mg, tablets, orally for one night only.
RamelteonDrug
Also called Rozerem™, TAK-375
Ramelteon 16 mg, tablets, orally for one night only
PlaceboDrug
Ramelteon placebo-matching tablets, orally for one night only
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg QD | Experimental | Not described Receives: Drug: Ramelteon |
| Ramelteon 16 mg QD | Experimental | Not described Receives: Drug: Ramelteon |
| 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.
Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory.
Measured: Day 1
Secondary outcomes (15)
Total Sleep Time.
Measured: Days 1 and 2.
Sleep Efficiency.
Measured: Days 1 and 2.
Wake Time after Persistent Sleep Onset.
Measured: Days 1 and 2.
Number of Awakenings after Persistent Sleep.
Measured: Days 1 and 2.
Subjective Sleep Latency.
Measured: Day 2
Subjective Total Sleep Time.
Measured: Day 2
Subjective Sleep Quality.
Measured: Day 2
Subjective Wake Time after Sleep Onset.
Measured: Day 2
Subjective Number of Awakenings.
Measured: Day 2
Subjective Ease of Falling Back to Sleep after Awakening.
Measured: Day 2
Stage 1 Nonrapid Eye Movement (NREM) Sleep
Measured: Day 2.
Stage 2 Nonrapid Eye Movement (NREM) Sleep
Measured: Day 2.
Stage 3/4 Nonrapid Eye Movement (NREM) Sleep
Measured: Day 2.
Latency to Rapid Eye Movement (REM) Sleep
Measured: Day 2.
Percentage of Total Sleep Time in REM Sleep
Measured: Day 2.
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 startDec 2002
- Primary completionMay 2003
- Study completionMay 2003
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 Transient 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 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
- NCT00671398
- Sponsor's protocol ID
- 01-02-TL-375-023
- Other IDs
- U1111-1114-8626
- Status last verified
- Feb 2012
- First submitted
- 1 May 2008
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zammit G, Schwartz H, Roth T, Wang-Weigand S, Sainati S, Zhang J. The effects of ramelteon in a first-night model of transient insomnia. Sleep Med. 2009 Jan;10(1):55-9. doi: 10.1016/j.sleep.2008.04.010. Epub 2008 Aug 8.
PubMed 18691937
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, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
- ClinicalTrials.gov ID
- NCT00671398
- Acronym / sponsor ID
- 01-02-TL-375-023
- Conditions
- Transient Insomnia
- Keywords
- Insomnia, Sleep Disorder, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- May 2003 (actual)
- Study completion
- May 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.
The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.
Detailed description
Insomnia is characterized by difficulties initiating and maintaining sleep, or 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 a selective melatonin-1 receptor agonist 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 evaluate the safety and efficacy of a single dose of Ramelteon in normal healthy subjects in a sleep lab model of transient insomnia. Participation is this study is anticipated to be about 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg QD | Experimental | Drug: Ramelteon |
| Ramelteon 16 mg QD | Experimental | Drug: Ramelteon |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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.
- Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
- Sleeps 6.5 to 8 hours per night and has a subjective sleep latency of less than or equal to 30 minutes.
- Body mass index between 18 and 34, inclusive.
Key exclusion criteria (39 listed)
- Any history of insomnia.
- Spent one or more nights in a sleep laboratory.
- Epworth Sleepiness Scale score of greater than 10.
- Known hypersensitivity to Ramelteon or related compounds, including melatonin.
- Previously participated in a study involving Ramelteon.
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 |
|---|---|---|
| RamelteonAlso: Rozerem™, TAK-375Ramelteon 8 mg, tablets, orally for one night only. | Drug | Ramelteon 8 mg QD |
| RamelteonAlso: Rozerem™, TAK-375Ramelteon 16 mg, tablets, orally for one night only | Drug | Ramelteon 16 mg QD |
| PlaceboRamelteon placebo-matching tablets, orally for one night only | Drug | Placebo |
Primary outcome
Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory.
Time frame: Day 1
15 secondary outcomes
Total Sleep Time.
Time frame: Days 1 and 2.
Sleep Efficiency.
Time frame: Days 1 and 2.
Wake Time after Persistent Sleep Onset.
Time frame: Days 1 and 2.
Number of Awakenings after Persistent Sleep.
Time frame: Days 1 and 2.
Subjective Sleep Latency.
Time frame: Day 2
Subjective Total Sleep Time.
Time frame: Day 2
Subjective Sleep Quality.
Time frame: Day 2
Subjective Wake Time after Sleep Onset.
Time frame: Day 2
Subjective Number of Awakenings.
Time frame: Day 2
Subjective Ease of Falling Back to Sleep after Awakening.
Time frame: Day 2
Stage 1 Nonrapid Eye Movement (NREM) Sleep
Time frame: Day 2.
Stage 2 Nonrapid Eye Movement (NREM) Sleep
Time frame: Day 2.
Stage 3/4 Nonrapid Eye Movement (NREM) Sleep
Time frame: Day 2.
Latency to Rapid Eye Movement (REM) Sleep
Time frame: Day 2.
Percentage of Total Sleep Time in REM Sleep
Time frame: Day 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.
- Results publication: PubMed 18691937Zammit G, Schwartz H, Roth T, Wang-Weigand S, Sainati S, Zhang J. The effects of ramelteon in a first-night model of transient insomnia. Sleep Med. 2009 Jan;10(1):55-9. doi: 10.1016/j.sleep.2008.04.010. Epub 2008 Aug 8.
- Rozerem Package InsertLink provided by the sponsor.
Related trials for Transient Insomnia
Active, not recruiting
Sleep Restriction Therapy for Insomnia in Primary Health Care
Insomnia
Not yet recruitingPhase 2
SM-1 vs. an Active Comparator in A Model of Transient Insomnia
Transient Insomnia
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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramelteon in people with Transient Insomnia, run by Takeda at 12 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 4 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 12 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. 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 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?
Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory. (time frame: Day 1). 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 NCT00671398, 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.