Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00235508 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
A Phase 4 study of Insomnia and Generalized Anxiety Disorder, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 4
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT00235508: Completed Phase 4 study of Insomnia and Generalized Anxiety Disorder, sponsored by Sumitomo Pharma America.
NCT00235508 is a Phase 4 study of Insomnia and Generalized Anxiety Disorder that has completed, run by Sumitomo Pharma America. The registered enrollment target is 420 participants, above the 167-participant average among 151 other Insomnia trials with a reported enrollment target (151% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00235508, a Phase 4 study of Insomnia and Generalized Anxiety Disorder, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.
Conditions Studied
Interventions
- DRUG Eszopiclone (Lunesta)
Study Locations (20)
California
- - Irvine
- - La Mesa
- - National City
- - Oceanside
- - Orange
- - Pasadena
- - Redlands
- - Riverside
- - San Diego
Florida
- - Coral Springs
- - Fort Lauderdale
- - Gainesville
- - Jacksonville
- - Orlando
- - Pembroke Pines
Arizona
- - Mesa
- - Scottsdale
Alabama
- - Birmingham
Connecticut
- - Farmington
District of Columbia
- - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2005-06 |
| Est. Completion | 2006-04 |
| Phase | Phase 4 |
What the finished NCT00235508 record still lists
NCT00235508 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 151 other Insomnia trials with a reported enrollment target (151% higher).
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Eszopiclone (Lunesta) is the first listed.
NCT00235508 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00235508 about?
NCT00235508 is a clinical study titled "Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder". To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placeb...
What is the current status of trial NCT00235508?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 420 participants. The study started on 2005-06. Estimated completion is 2006-04.
What conditions does trial NCT00235508 study?
This clinical trial studies the following conditions: Insomnia, Generalized Anxiety Disorder.
What interventions are being tested in trial NCT00235508?
The interventions under investigation include: Eszopiclone (Lunesta) (DRUG).
Who is sponsoring clinical trial NCT00235508?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00235508 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00235508's enrollment target sits among peer trials
420 15th of 151 higher than 137 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
-
Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms
RECRUITING · Phase 4
-
Enhancing Hypnotic Medication Discontinuation in Primary Care
RECRUITING · Phase 4
-
Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes
RECRUITING · Phase 4
-
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
ACTIVE NOT RECRUITING · Phase 4
-
Solriamfetol and CBT-I in Patients With Insomnia Disorder
ACTIVE NOT RECRUITING · Phase 4
-
A Pilot Study of Suvorexant for Insomnia in Parkinson Disease
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01790152 · 420 participants
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
- NCT02701244 · 420 participants
A Registry Study of Breast Microseed Treatment
- NCT02966665 · 420 participants · Phase 1
: Vascular Function in Health and Disease
- NCT04149743 · 420 participants · NA
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia