Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT02058992
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2014-02-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: