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Trial record 1 of 1 for:    293-101
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Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

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ClinicalTrials.gov Identifier: NCT02058992
Recruitment Status : Completed
First Posted : February 11, 2014
Results First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief 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.

Condition or disease Intervention/treatment
Insomnia Drug: Ramelteon

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.


Study Type : Observational
Actual Enrollment : 3339 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
Study Start Date : July 2010
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon
U.S. FDA Resources

Group/Cohort Intervention/treatment
Ramelteon 8 mg administered orally once daily Drug: Ramelteon
Ramelteon 8 mg tablets
Other Name: Rozerem



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Sleep Status: Sleep Onset Latency [ Time Frame: Baseline and Week 4 ]
    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.

  2. Sleep Status: Total Sleep Time [ Time Frame: Baseline and Week 4 ]
    Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.

  3. Sleep Status: Number of Awakenings [ Time Frame: Baseline and Week 4 ]
    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.

  4. Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Insomnia
Criteria

Inclusion Criteria:

1. Sleep-onset difficulty associated with insomnia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058992


Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02058992     History of Changes
Other Study ID Numbers: 293-101
JapicCTI-132358 ( Registry Identifier: JapicCTI )
JapicCTI-R150751 ( Registry Identifier: JapicCTI )
First Posted: February 11, 2014    Key Record Dates
Results First Posted: July 14, 2016
Last Update Posted: July 14, 2016
Last Verified: June 2016

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders