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Trial record 1 of 1 for:    293-011
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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 −

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02153086
First received: May 29, 2014
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Insomnia
Drug: Ramelteon

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 −

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Sleep Status: Sleep Onset Latency [ Time Frame: Baseline, Week 4 and Month 12 ]
    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).

  • Sleep Status: Total Sleep Time [ Time Frame: Baseline, Week 4 and Month 12 ]
    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).

  • Sleep Status: Number of Awakenings [ Time Frame: Baseline, Week 4 and Month 12 ]
    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).

  • 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) ]
    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).

  • 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) ]
    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).

  • 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) ]
    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).

  • 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) ]
    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).

  • 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) ]
    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).

  • 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) ]
    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).

  • 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) ]
    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).


Enrollment: 236
Study Start Date: March 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ramelteon 8 mg Tablets Drug: Ramelteon
Ramelteon tablets 8 mg
Other Name: Rozerem 8 mg Tablets

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.
  Eligibility

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:

-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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02153086

Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02153086     History of Changes
Other Study ID Numbers: 293-011
Study First Received: May 29, 2014
Results First Received: August 17, 2016
Last Updated: August 17, 2016

Keywords provided by Takeda:
Pharmacological therapy

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

ClinicalTrials.gov processed this record on May 25, 2017