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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 is a Phase 4 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 388 participants.
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.
Interventions
- DRUG Placebo
- DRUG Eszopiclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00386334
The ClinicalTrials.gov registry entry for NCT00386334 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 388 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00386334 reports 0 study locations.
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.
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