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NCT00492232 · ClinicalTrials.gov registry record · Phase 4
Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia
A Phase 4 study of Chronic Insomnia, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 135
- Enrollment target
- 20
- Study locations
NCT00492232: Completed Phase 4 study of Chronic Insomnia, sponsored by Takeda.
NCT00492232 is a Phase 4 study of Chronic Insomnia that has completed, run by Takeda. The registered enrollment target is 135 participants, below the 25,386-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00492232, a Phase 4 study of Chronic Insomnia, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 135 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.
Primary Outcome
Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.
Conditions Studied
Interventions
- DRUG Ramelteon and zolpidem
- DRUG Placebo and zolpidem
Study Locations (20)
California
- - Anaheim
- - Fountain Valley
- - La Mesa
- - Los Angeles
- - Redlands
- - San Diego
- - San Francisco
- - Santa Monica
Florida
- - Clearwater
- - Hollywood
- - Kissimmee
- - Naples
- - Pembroke Pines
- - Winter Park
Georgia
- - Atlanta
- - Austell
Arkansas
- - Hot Springs
Colorado
- - Denver
Idaho
- - Boise
Kentucky
- - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
What the finished NCT00492232 record still lists
NCT00492232 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 25,386-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Chronic Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Ramelteon and zolpidem is the first listed.
NCT00492232 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00492232 about?
NCT00492232 is a clinical study titled "Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia". The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.
What is the current status of trial NCT00492232?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 135 participants. The study started on 2007-04. Estimated completion is 2008-05.
What conditions does trial NCT00492232 study?
This clinical trial studies the following conditions: Chronic Insomnia.
What interventions are being tested in trial NCT00492232?
The interventions under investigation include: Ramelteon and zolpidem (DRUG), Placebo and zolpidem (DRUG).
Who is sponsoring clinical trial NCT00492232?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00492232 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00492232's enrollment target sits among peer trials
135 6th of 11 higher than 6 of 11 other Chronic Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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