BalancePhase 3NCT00237497
Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia
A Phase 3 study testing Ramelteon and Zopiclone in people with Balance, run by Takeda at 1 site in United Kingdom.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Balance
- What is being tested?
- Ramelteon and Zopiclone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2005to Oct 2006
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Men or women aged 18 to 64 years, inclusive.
- Capable of understanding and willing to comply with the protocol and had to fully understand and sign the informed consent document at screening prior to any study-related procedures being performed.
- In addition, subjects had to meet the following study-specific criteria:
- Chronic insomnia as defined by:
- A complaint of difficulty initiating or maintaining sleep or of nonrestorative sleep that lasted for at least 3 months.
- The sleep disturbance (or associated daytime fatigue) caused clinically significant distress or impairment in social, occupational, or other important areas of functioning.
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- The disturbance did not occur exclusively during the course of narcolepsy, breathing related sleep disorder, circadian rhythm sleep disorder or a parasomnia.
- The sleep disturbance did not occur exclusively during the course of another mental disorder (eg, major depressive disorder, generalized anxiety disorder, a delirium).
- The disturbance was not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition.
- Based on sleep history, a subjective sleep latency (sSL) ≥45 minutes.
- Based on sleep history, a subjective total sleep time (sTST) ≤6.5 hours.
- Based on sleep history, a mean LPS of ≥20 minutes on 2 consecutive screening nights with neither night <15 minutes.
- Based on sleep history, their habitual bedtime was between 10:00 PM and 1:00 AM.
- Able to stand with eyes closed, arms at side and feet apart at hips width for at least 1 minute with out taking a step.
- A body mass index (BMI) between 18 and 34, inclusive.
- Used pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.
- Agreed to discontinue use of all pharmacological sleep aids 1 week prior to the dose of singleblind study medication and throughout the entire duration of the study.
- Women of childbearing potential were non-pregnant and non-lactating and had appropriate birth control (barrier methods, hormonal contraceptives, and/or intrauterine devices) for the entire duration of the study (women who were not of childbearing potential were postmenopausal for 1 year or had a history of hysterectomy and/or bilateral oophorectomy).
Who cannot join
- A known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin and melatonin related compounds.
- Participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first night of single-blind study medication (whichever was longer).
- Had sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication, or had flown across greater than 3 time zones within 7 days prior to screening.
- Participated in a weight-loss program or had substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
- A history of, or currently had, conditions that would affect balance such as:
- Orthostatic hypotension.
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- Dizziness.
- Vertigo, or benign paroxysmal positional vertigo.
- A history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, periodic leg movement syndrome, or fibromyalgia.
- A history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months.
- A history of drug addiction or drug abuse within the past 12 months.
- A history of alcohol abuse within the past 12 months or regularly consumed more than 14 alcoholic drinks per week or consumed any alcoholic drinks within 24 hours of all polysomnography visits.
- A current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the first night of single-blind study medication.
- Used tobacco products during nightly awakenings.
- Used melatonin, or other drugs or supplements known to affect sleep/wake function within 1 week or 5 half-lives of the drug (whichever was longer) prior to the first day of single-blind study medication.
- Used any central nervous system (CNS) medication within 1 week or 5 half lives of the drug (whichever was longer) prior to the first day of single-blind study medication.
- Intended to continue taking any disallowed medication or any prescription medication, over the counter (OTC) or herbal medication known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication.
- Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram (ECG), or clinical laboratory tests.
- A positive urine drug screen including alcohol at screening or a positive breathalyzer test at each check-in.
- An apnea hypopnea index (per hour of sleep) >10 as seen on PSG, on the first night of the PSG screening.
- Periodic leg movement with arousal index (per hour of sleep) >10 as seen on PSG, on the first night of PSG 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.
- Had lower limb prosthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Ramelteon Compared to Placebo With Zopiclone as a Reference Arm in Adults With Chronic Insomnia
The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia
Read the detailed description
A vast majority of people are affected by chronic insomnia in the western world. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
This study will examine the effect of ramelteon on balance/postural stability on Night 14 at peak plasma concentration levels, compared with placebo and using zopiclone as the reference arm.
- Conditions
- Balance
- Being tested
- Ramelteon, Zopiclone, Placebo
- Keywords
- Insomnia, Center of Pressure, Postural Sway, Drug Therapy, Balance and Stability
- 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.
RamelteonDrug
Also called Rozerem, TAK-375
Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.
ZopicloneDrug
Also called Zimovane, Imovane, Rovane
Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights.
PlaceboDrug
Placebo-matching tablets, orally, once daily for up to 28 nights.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg QD | Experimental | Not described Receives: Drug: Ramelteon |
| Zopiclone 7.5 mg QD | Active comparator | Not described Receives: Drug: Zopiclone |
| Placebo QD | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated Area of Center of Pressure (COP) in cm2 recorded on the AccuSway® balance platform during Night 14 with Eyes Open
Measured: 1.5 to 2 hours Postdose on Night 14.
Secondary outcomes (19)
Calculated Area of Center of Pressure (COP) in cm2 recorded on the AccuSway® balance platform during Night 14 with Eyes Closed.
Measured: 1.5 to 2 hours Postdose on Night 14.
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 1-2).
Measured: Nights 1 and 2.
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 27-28).
Measured: Nights 27 and 28.
Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2.
Subjective sleep latency Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28.
Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2.
Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28.
Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2.
Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28.
Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2.
Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28.
Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2.
Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28.
Restorative Nature of Sleep Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2.
Restorative nature of sleep Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28.
Morning Alertness Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2
Morning Alertness Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28
Morning Ability to Concentrate Measured by a Post-sleep Questionnaire (Nights 1-2).
Measured: Nights 1 and 2
Morning Ability to Concentrate Measured by a Post-sleep Questionnaire (Nights 27-28).
Measured: Nights 27 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJul 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies 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
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Principal investigator, Takeda Global Research & Development Centre (Europe)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237497
- Sponsor's protocol ID
- TAK-375-EC301
- Other IDs
- U1111-1114-1542, 2004-004350-91, 2004
- Status last verified
- Jan 2012
- First submitted
- 11 Oct 2005
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Ramelteon Compared to Placebo With Zopiclone as a Reference Arm in Adults With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT00237497
- Acronym / sponsor ID
- TAK-375-EC301
- Conditions
- Balance
- Keywords
- Insomnia, Center of Pressure, Postural Sway, Drug Therapy, Balance and Stability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Oct 2005 (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 the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia
Detailed description
A vast majority of people are affected by chronic insomnia in the western world. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
This study will examine the effect of ramelteon on balance/postural stability on Night 14 at peak plasma concentration levels, compared with placebo and using zopiclone as the reference arm.
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 |
| Zopiclone 7.5 mg QD | Active comparator | Drug: Zopiclone |
| Placebo QD | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Men or women aged 18 to 64 years, inclusive.
- Capable of understanding and willing to comply with the protocol and had to fully understand and sign the informed consent document at screening prior to any study-related procedures being performed.
- Chronic insomnia as defined by:
- Based on sleep history, a subjective sleep latency (sSL) ≥45 minutes.
- Based on sleep history, a subjective total sleep time (sTST) ≤6.5 hours.
Key exclusion criteria (23 listed)
- A known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin and melatonin related compounds.
- Participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first night of single-blind study medication (whichever was longer).
- Had sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication, or had flown across greater than 3 time zones within 7 days prior to screening.
- Participated in a weight-loss program or had substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
- A history of, or currently had, conditions that would affect balance such as:
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, once daily for up to 28 nights. | Drug | Ramelteon 8 mg QD |
| ZopicloneAlso: Zimovane, Imovane, RovaneZopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights. | Drug | Zopiclone 7.5 mg QD |
| PlaceboPlacebo-matching tablets, orally, once daily for up to 28 nights. | Drug | Placebo QD |
Primary outcome
Calculated Area of Center of Pressure (COP) in cm2 recorded on the AccuSway® balance platform during Night 14 with Eyes Open
Time frame: 1.5 to 2 hours Postdose on Night 14.
19 secondary outcomes
Calculated Area of Center of Pressure (COP) in cm2 recorded on the AccuSway® balance platform during Night 14 with Eyes Closed.
Time frame: 1.5 to 2 hours Postdose on Night 14.
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 1-2).
Time frame: Nights 1 and 2.
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 27-28).
Time frame: Nights 27 and 28.
Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2.
Subjective sleep latency Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28.
Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2.
Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28.
Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2.
Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28.
Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2.
Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28.
Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2.
Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28.
Restorative Nature of Sleep Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2.
Restorative nature of sleep Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28.
Morning Alertness Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2
Morning Alertness Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28
Morning Ability to Concentrate Measured by a Post-sleep Questionnaire (Nights 1-2).
Time frame: Nights 1 and 2
Morning Ability to Concentrate Measured by a Post-sleep Questionnaire (Nights 27-28).
Time frame: Nights 27 and 28
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 Feb 2012.
- 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.
Medical Director Clinical Science principal investigator
Takeda Global Research & Development Centre (Europe)
1 site 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 and Zopiclone in people with Balance, run by Takeda at 1 site in United Kingdom.
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 18 inclusion and 23 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 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 1 site in United Kingdom. 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?
Calculated Area of Center of Pressure (COP) in cm2 recorded on the AccuSway® balance platform during Night 14 with Eyes Open (time frame: 1.5 to 2 hours Postdose on Night 14.). 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 Feb 2012.