Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
NCT00235508 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00235508
The ClinicalTrials.gov registry entry for NCT00235508 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00235508 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00235508?
The interventions under investigation include: Eszopiclone (Lunesta) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00235508?
This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.