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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 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.

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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

Insomnia Generalized Anxiety Disorder

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

FieldValue
Enrollment Target 420 participants
Start Date 2005-06
Est. Completion 2006-04
Phase Phase 4

Sponsor

Sumitomo Pharma America

168 total trials

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What the Registry Record Tells You About NCT00235508

The ClinicalTrials.gov registry entry for NCT00235508 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 167-participant average among 151 other Insomnia trials with a reported enrollment target (151% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.