Clinical trial NCT02153086: 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 -
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 -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Insomnia

Brief 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.

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 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

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Sleep Status: Sleep Onset Latency
timeFrame: Baseline, Week 4 and Month 12
measure: Sleep Status: Total Sleep Time
timeFrame: Baseline, Week 4 and Month 12
measure: Sleep Status: Number of Awakenings
timeFrame: Baseline, Week 4 and Month 12
measure: Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset
timeFrame: At Week 4, 52, and final assessment (up to 12 months)
measure: Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration
timeFrame: At Week 4, 52, and final assessment (up to 12 months)
measure: Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality
timeFrame: At Week 4, 52, and final assessment (up to 12 months)
measure: Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening
timeFrame: At Week 4, 52, and final assessment (up to 12 months)
measure: Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning
timeFrame: At Week 4, 52, and final assessment (up to 12 months)
measure: Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence
timeFrame: At Week 4, 52, and final assessment (up to 12 months)
measure: Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function
timeFrame: At Week 4, 52, and final assessment (up to 12 months)
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: