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NCT00352144 · ClinicalTrials.gov registry record · Phase 3
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
A Phase 3 study of Primary Insomnia, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 830
- Enrollment target
- 20
- Study locations
NCT00352144: Completed Phase 3 study of Primary Insomnia, sponsored by Sumitomo Pharma America.
NCT00352144 is a Phase 3 study of Primary Insomnia that has completed, run by Sumitomo Pharma America. The registered enrollment target is 830 participants, above the 57-participant average among 12 other Primary Insomnia trials with a reported enrollment target (1356% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00352144, a Phase 3 study of Primary Insomnia, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 830 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Eszopiclone
Study Locations (20)
Florida
- - Clearwater
- - Jacksonville
- - Jupiter
- - Naples
- - Orlando
- - Pembroke Pines
- - Pinellas Park
California
- - Anaheim
- - Irvine
- - Oakland
- - Redlands
- - San Diego
Colorado
- - Aurora
- - Denver
- - Longmont
- - Pueblo
Alabama
- - Birmingham
- - Huntsville
Arizona
- - Phoenix
- - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 830 participants |
| Start Date | 2003-10 |
| Est. Completion | 2004-10 |
| Phase | Phase 3 |
What the finished NCT00352144 record still lists
NCT00352144 is an interventional study that assigns participants to a tested intervention. The registered 830 participants enrollment target is mid-sized for trials with a published cap, above the 57-participant average among 12 other Primary Insomnia trials with a reported enrollment target (1356% higher).
The record links to 1 condition, with Primary Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00352144 names 20 study sites across 5 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00352144 about?
NCT00352144 is a clinical study titled "6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia". To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.
What is the current status of trial NCT00352144?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 830 participants. The study started on 2003-10. Estimated completion is 2004-10.
What conditions does trial NCT00352144 study?
This clinical trial studies the following conditions: Primary Insomnia.
What interventions are being tested in trial NCT00352144?
The interventions under investigation include: Placebo (DRUG), Eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00352144?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00352144 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary 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 NCT00352144's enrollment target sits among peer trials
830 1st of 12 higher than 12 of 12 other Primary Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary 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
-
The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
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-
Sleep Homeostasis in Primary Insomnia
COMPLETED · NA
-
A High Density EEG Comparison of Sleep Patterns in Insomnia
COMPLETED
-
Two Contrasting Interventions for Sleep Management
COMPLETED · Phase 2
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