InsomniaNCT02058992

Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

An observational study of Insomnia, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia. 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: 3,339 participants
Where: No sites listed yet
Study dates: Jul 2010to Apr 2013
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

1. Sleep-onset difficulty associated with insomnia

Who cannot join

Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
Patients with severe liver dysfunction
Patients taking fluvoxamine maleate

About this study

Official title: Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

Read the detailed description

This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)

The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.

Conditions: Insomnia
Being tested: Ramelteon
Keywords: Drug 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
Ramelteon 8 mg tablets

Study groups in NCT02058992
Study group	Role	What they receive
Ramelteon 8 mg administered orally once daily		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 (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE 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 6 weeks
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to 6 weeks

Secondary outcomes (4)

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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4
PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. 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 for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Apr 2013

First posted11 Feb 2014 (estimated)
Study startJul 2010
Primary completionApr 2013
Study completionApr 2013

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: 3,339 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02058992
Sponsor's protocol ID: 293-101
Other IDs: JapicCTI-132358, JapicCTI-R150751
Status last verified: Jun 2016
First submitted: 7 Feb 2014
Last updated: 14 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
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Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder

All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
ClinicalTrials.gov ID: NCT02058992
Acronym / sponsor ID: 293-101
Conditions: Insomnia
Keywords: Drug therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,339 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 11 Feb 2014 (estimated)
Results: Posted 14 Jul 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 study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

Detailed description

The usual adult dosage 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 administered orally once daily	–	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)

1. Sleep-onset difficulty associated with insomnia

Key exclusion criteria (3 listed)

Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
Patients with severe liver dysfunction
Patients 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: RozeremRamelteon 8 mg tablets	Drug	Ramelteon 8 mg administered orally once daily

Primary outcome

Number of Participants Reporting One or More Adverse Drug Reactions
Time frame: Baseline up to 6 weeks
Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE 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.
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Time frame: Baseline up to 6 weeks
Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

4 secondary outcomes

Sleep Status: Sleep Onset Latency
Time frame: Baseline and Week 4
Sleep Status: Total Sleep Time
Time frame: Baseline and Week 4
Sleep Status: Number of Awakenings
Time frame: Baseline and Week 4
Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4
Time frame: Week 4

Results and safety

Results posted to the registry on 14 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ramelteon	3,339	3,223

Primary outcome: Number of Participants Reporting One or More Adverse Drug Reactions

Time frame: Baseline up to 6 weeks. Number. Unit: participants

Measure	Ramelteon n = 3223
Value	109

Population analysed: Safety analysis set was defined as participants who were enrolled and completed the study.

Primary outcome: Number of Participants Reporting One or More Serious Adverse Drug Reactions

Time frame: Baseline up to 6 weeks. Number. Unit: participants

Measure	Ramelteon n = 3223
Value	1

Population analysed: SAS was defined as participants who were enrolled and completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 6 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ramelteon	1 of 3,223 (0%)	37 of 3,223 (1.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder

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

Questions about this trial

What is this clinical trial studying?

An observational study of Insomnia, 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 1 inclusion and 3 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 14 Jul 2016. 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. 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 14 Jul 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 6 weeks). The study lists 2 primary outcomes in all. 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 NCT02058992.

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 14 Jul 2016.