InsomniaNCT02153086
Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -
An observational study of Insomnia, run by Takeda at 2 sites in Japan.
Trial summary
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insomnia
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- How many people
- 236 participants
- Where
- 2 sitesJapan
- Study dates
- Mar 2011to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Insomnia
Who may be able to join
- -Participants with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets
Who cannot join
- Participants with contraindications to Rozerem Tablets.
- Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets.
- Participants with severe liver dysfunction.
- Participants taking fluvoxamine maleate
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Rozerem 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Associated With Sleep-onset Difficulty > - Transitional Survey From the Preceding Drug-use Survey -
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.
Read the detailed description
This survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.
- Conditions
- Insomnia
- Being tested
- Ramelteon
- Keywords
- Pharmacological 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.
RamelteonDrug
Also called Rozerem 8 mg Tablets
Ramelteon tablets 8 mg
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg Tablets | Not described Receives: Drug: Ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Adverse Drug Reactions
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Measured: Baseline up to 12 months
Secondary outcomes (10)
Sleep Status: Sleep Onset Latency
Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Measured: Baseline, Week 4 and Month 12
Sleep Status: Total Sleep Time
Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Measured: Baseline, Week 4 and Month 12
Sleep Status: Number of Awakenings
Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).
Measured: Baseline, Week 4 and Month 12
Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset
Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Measured: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration
Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Measured: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality
Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Measured: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening
Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Measured: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning
Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Measured: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence
Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Measured: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function
Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12).
Measured: At Week 4, 52, and final assessment (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMar 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Postmarketing Group Manager, Study chair, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153086
- Sponsor's protocol ID
- 293-011
- Status last verified
- Aug 2016
- First submitted
- 29 May 2014
- Last updated
- 13 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rozerem 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Associated With Sleep-onset Difficulty > - Transitional Survey From the Preceding Drug-use Survey -
- ClinicalTrials.gov ID
- NCT02153086
- Acronym / sponsor ID
- 293-011
- Conditions
- Insomnia
- Keywords
- Pharmacological therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Posted 13 Oct 2016
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 survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.
Detailed description
This survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg Tablets | – | Drug: Ramelteon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Insomnia
Key inclusion criteria (1 listed)
- -Participants with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets
Key exclusion criteria (4 listed)
- Participants with contraindications to Rozerem Tablets.
- Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets.
- Participants with severe liver dysfunction.
- Participants taking fluvoxamine maleate
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 8 mg TabletsRamelteon tablets 8 mg | Drug | Ramelteon 8 mg Tablets |
Primary outcome
Number of Participants Reporting One or More Adverse Drug Reactions
Time frame: Baseline up to 12 months
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
10 secondary outcomes
Sleep Status: Sleep Onset Latency
Time frame: Baseline, Week 4 and Month 12
Sleep Status: Total Sleep Time
Time frame: Baseline, Week 4 and Month 12
Sleep Status: Number of Awakenings
Time frame: Baseline, Week 4 and Month 12
Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset
Time frame: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration
Time frame: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality
Time frame: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening
Time frame: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning
Time frame: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence
Time frame: At Week 4, 52, and final assessment (up to 12 months)
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function
Time frame: At Week 4, 52, and final assessment (up to 12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Postmarketing Group Manager study chair
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Takeda at 2 sites in Japan.
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 1 inclusion and 4 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting One or More Adverse Drug Reactions (time frame: Baseline up to 12 months). 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 13 Oct 2016.