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NCT00671125 · ClinicalTrials.gov registry record · Phase 3

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

A Phase 3 study of Chronic Insomnia, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
405
Enrollment target
20
Study locations

NCT00671125 is a Phase 3 study of Chronic Insomnia that has completed, run by Takeda. The registered enrollment target is 405 participants, below the 25,362-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT00671125, a Phase 3 study of Chronic Insomnia, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
405 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep

Conditions Studied

Chronic Insomnia

Interventions

  • DRUG Placebo
  • DRUG Ramelteon

Study Locations (20)

California

  • - Anaheim
  • - Oakland
  • - San Diego
  • - San Francisco
  • - Santa Monica

Florida

  • - Miami
  • - Pembroke Pines

Alabama

  • - Birmingham

Arizona

  • - Scottsdale

Arkansas

  • - Hot Springs

Georgia

  • - Atlanta

Illinois

  • - Chicago

Kansas

  • - Overland Park

Trial Details

FieldValue
Enrollment Target 405 participants
Start Date 2003-01
Est. Completion 2003-09
Phase Phase 3

Sponsor

Takeda

408 total trials

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What the Registry Record Tells You About NCT00671125

The ClinicalTrials.gov registry entry for NCT00671125 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 405 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 25,362-participant average among 11 other Chronic Insomnia trials with a reported enrollment target (98% 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 Placebo is the first listed.

NCT00671125 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT00671125 about?

NCT00671125 is a clinical study titled "Study of Efficacy of Ramelteon in Adults With Chronic Insomnia". The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep

What is the current status of trial NCT00671125?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2003-01. Estimated completion is 2003-09.

What conditions does trial NCT00671125 study?

This clinical trial studies the following conditions: Chronic Insomnia.

What interventions are being tested in trial NCT00671125?

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

Who is sponsoring clinical trial NCT00671125?

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

Where is trial NCT00671125 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, 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.