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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 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.

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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

Primary Insomnia

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

FieldValue
Enrollment Target 830 participants
Start Date 2003-10
Est. Completion 2004-10
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

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What the Registry Record Tells You About NCT00352144

The ClinicalTrials.gov registry entry for NCT00352144 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 830 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 57-participant average among 12 other Primary Insomnia trials with a reported enrollment target (1356% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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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.