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NCT00492232 · ClinicalTrials.gov registry record · Phase 4

Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

A Phase 4 study of Chronic Insomnia, sponsored by Takeda.

Completed
Registry status
Phase 4
Development phase
135
Enrollment target
20
Study locations

NCT00492232 is a Phase 4 study of Chronic Insomnia that has completed, run by Takeda. The registered enrollment target is 135 participants, below the 25,386-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00492232, a Phase 4 study of Chronic Insomnia, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 4
Development phase
135 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.

Conditions Studied

Interventions

  • DRUG Ramelteon and zolpidem
  • DRUG Placebo and zolpidem

Study Locations (20)

California

  • - Anaheim
  • - Fountain Valley
  • - La Mesa
  • - Los Angeles
  • - Redlands
  • - San Diego
  • - San Francisco
  • - Santa Monica

Florida

  • - Clearwater
  • - Hollywood
  • - Kissimmee
  • - Naples
  • - Pembroke Pines
  • - Winter Park

Georgia

  • - Atlanta
  • - Austell

Arkansas

  • - Hot Springs

Colorado

  • - Denver

Idaho

  • - Boise

Kentucky

  • - Louisville

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2007-04
Est. Completion 2008-05
Phase Phase 4

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT00492232

The ClinicalTrials.gov registry entry for NCT00492232 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 25,386-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (99% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Ramelteon and zolpidem is the first listed.

NCT00492232 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00492232 about?

NCT00492232 is a clinical study titled "Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia". The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.

What is the current status of trial NCT00492232?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 135 participants. The study started on 2007-04. Estimated completion is 2008-05.

What conditions does trial NCT00492232 study?

This clinical trial studies the following conditions: Chronic Insomnia.

What interventions are being tested in trial NCT00492232?

The interventions under investigation include: Ramelteon and zolpidem (DRUG), Placebo and zolpidem (DRUG).

Who is sponsoring clinical trial NCT00492232?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00492232 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. 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.