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NCT00593736 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
A Phase 2 study of Sleep Disorders, Circadian Rhythm, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT00593736: Completed Phase 2 study of Sleep Disorders, Circadian Rhythm, sponsored by Takeda.
NCT00593736 is a Phase 2 study of Sleep Disorders, Circadian Rhythm that has completed, run by Takeda. The registered enrollment target is 132 participants, above the 31-participant average among 4 other Sleep Disorders, Circadian Rhythm trials with a reported enrollment target (326% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00593736, a Phase 2 study of Sleep Disorders, Circadian Rhythm, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
Primary Outcome
The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ramelteon
Study Locations (20)
Florida
- - Hallandale Bch
- - Naples
- - Pembroke Pines
- - South Miami
- - Spring Hill
- - St. Petersburg
- - Winter Park
California
- - Fountain Valley
- - Glendale
- - Los Angeles
- - San Diego
- - Santa Monica
- - Tustin
Arkansas
- - Hot Springs
- - Little Rock
Georgia
- - Atlanta
- - Gainesville
Alabama
- - Birmingham
Arizona
- - Tucson
Colorado
- - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00593736 record still lists
NCT00593736 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 31-participant average among 4 other Sleep Disorders, Circadian Rhythm trials with a reported enrollment target (326% higher).
The record links to 1 condition, with Sleep Disorders, Circadian Rhythm appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00593736 names 20 study sites across 7 states, led by Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00593736 about?
NCT00593736 is a clinical study titled "Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome". The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
What is the current status of trial NCT00593736?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2007-10. Estimated completion is 2008-05.
What conditions does trial NCT00593736 study?
This clinical trial studies the following conditions: Sleep Disorders, Circadian Rhythm.
What interventions are being tested in trial NCT00593736?
The interventions under investigation include: Placebo (DRUG), Ramelteon (DRUG).
Who is sponsoring clinical trial NCT00593736?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00593736 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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