Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-31 @ 2:49 AM
Study NCT ID:
NCT00915135
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2009-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Ramelteon on Chronic Insomnia
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Double-Blind, Dose-Response, Cross-Over Study of TAK-375 With Chronic Insomnia (Phase II Study) -- Polysomnographic Evaluation
Status:
COMPLETED
Status Verified Date:
2010-05
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 determine the dose response of Ramelteon, once daily (QD), in Japanese subjects with Chronic Insomnia
Detailed Description:
Complaints of sleep disorder are increasing with today's aging society and changing lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede one's social life, leading to reduced productivity and sometimes accidents through carelessness.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1115-2062 | REGISTRY | WHO | View |