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NCT00386334 · ClinicalTrials.gov registry record · Phase 4
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
A Phase 4 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 4
- Development phase
- 388
- Enrollment target
NCT00386334: Completed Phase 4 study, sponsored by Sumitomo Pharma America.
NCT00386334 is a Phase 4 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 388 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00386334, a Phase 4 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 388 participants
- Enrollment target
Study Summary
To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.
Primary Outcome
The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Interventions
- DRUG Placebo
- DRUG Eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT00386334 record still lists
NCT00386334 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00386334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00386334 about?
NCT00386334 is a clinical study titled "A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia". To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, ...
What is the current status of trial NCT00386334?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 388 participants. The study started on 2006-10. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00386334?
The interventions under investigation include: Placebo (DRUG), Eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00386334?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00386334's enrollment target sits among peer trials
388 222nd of 2000 higher than 1,779 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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