Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00914862 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults

A Phase 1 study of Insomnia, sponsored by Takeda.

Completed
Registry status
Phase 1
Development phase
56
Enrollment target
2
Study locations

NCT00914862 is a Phase 1 study of Insomnia that has completed, run by Takeda. The registered enrollment target is 56 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00914862, a Phase 1 study of Insomnia, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.

Conditions Studied

Interventions

  • DRUG Ramelteon

Study Locations (2)

Kansas

  • - Overland Park

Michigan

  • - Kalamazoo

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2009-11
Est. Completion 2011-04
Phase Phase 1

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT00914862

The ClinicalTrials.gov registry entry for NCT00914862 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (67% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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

NCT00914862 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kansas, Michigan.

Frequently Asked Questions

What is clinical trial NCT00914862 about?

NCT00914862 is a clinical study titled "Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults". The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.

What is the current status of trial NCT00914862?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2009-11. Estimated completion is 2011-04.

What conditions does trial NCT00914862 study?

This clinical trial studies the following conditions: Insomnia.

What interventions are being tested in trial NCT00914862?

The interventions under investigation include: Ramelteon (DRUG).

Who is sponsoring clinical trial NCT00914862?

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

Where is trial NCT00914862 being conducted?

This trial has 2 study locations across Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Insomnia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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.