Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414102
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2006-12-19
Brief Title:
Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Parallel Group Study to Demonstrate the Subjective Treatment Effects of Ramelteon on Sleep Using a Post Sleep Questionnaire - Interactive Voice Response System PSQ-IVRS in an At-Home Setting in an Adult Population With Chronic Insomnia
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 subjective treatment effects of ramelteon once daily QD on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia
Detailed Description:
Approximately 60 to 70 million adults in the United States alone are affected by insomnia Daytime symptoms of insomnia include tiredness lack of energy difficulty concentrating and irritability Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related conditions that relate to work productivity health care utilization and risk of depression Insomnia is associated with diminished work output absenteeism and greater rates of accidents
Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset under the brand name of Rozerem
This study will be comprised of two groups of subjects 1 an outpatient group and 2 an inpatient group The inpatient group will be used as reference arm as previously conducted studies in the sleep laboratory setting Study participation is anticipated to be about 50 days approximately 175 months
Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep onset under the brand name of Rozerem
This study will be comprised of two groups of subjects 1 an outpatient group and 2 an inpatient group The inpatient group will be used as reference arm as previously conducted studies in the sleep laboratory setting Study participation is anticipated to be about 50 days approximately 175 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1115-2043 | REGISTRY | WHO | None |