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COMPLETED Phase 3

6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

NCT00352144 · View on ClinicalTrials.gov ↗

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

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

Sponsor

Sumitomo Pharma America

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00352144

The ClinicalTrials.gov registry entry for NCT00352144 describes a study currently listed as completed. It is categorized as Phase 3, 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 830 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 1 condition, with Primary Insomnia appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT00352144 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Colorado. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00352144?

The interventions under investigation include: Placebo (DRUG), Eszopiclone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00352144?

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 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.

Related

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