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NCT00492011 · ClinicalTrials.gov registry record · Phase 4

Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

A Phase 4 study of Circadian Dysregulation, sponsored by Takeda.

Completed
Registry status
Phase 4
Development phase
110
Enrollment target
4
Study locations

NCT00492011 is a Phase 4 study of Circadian Dysregulation that has completed, run by Takeda. The registered enrollment target is 110 participants, above the 60-participant average among 10 other Circadian Dysregulation trials with a reported enrollment target (83% higher). The trial reports 4 study locations across 3 states.

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The verdict

NCT00492011, a Phase 4 study of Circadian Dysregulation, has completed, sponsored by Takeda.

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

Study Summary

The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Ramelteon

Study Locations (4)

Florida

  • - Miami
  • - Pembroke Pines

Hawaii

  • - Honolulu

New York

  • - New York

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2007-02
Est. Completion 2007-08
Phase Phase 4

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT00492011

The ClinicalTrials.gov registry entry for NCT00492011 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 60-participant average among 10 other Circadian Dysregulation trials with a reported enrollment target (83% higher). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Circadian Dysregulation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00492011 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Florida, Hawaii, New York.

Frequently Asked Questions

What is clinical trial NCT00492011 about?

NCT00492011 is a clinical study titled "Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers". The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.

What is the current status of trial NCT00492011?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2007-02. Estimated completion is 2007-08.

What conditions does trial NCT00492011 study?

This clinical trial studies the following conditions: Circadian Dysregulation.

What interventions are being tested in trial NCT00492011?

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

Who is sponsoring clinical trial NCT00492011?

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

Where is trial NCT00492011 being conducted?

This trial has 4 study locations across Florida, Hawaii, New York. 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.