Completed PHASE3 INTERVENTIONAL 3-arm NCT00671567

Ramelteon in Adults With Chronic Insomnia

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Adults With Chronic Insomnia

Sponsor: Takeda

Conditions Chronic Insomnia

Interventions Placebo Ramelteon

Updated 7 times since 2017 Last updated: Nov 16, 2012 Started: Dec 31, 2002 Primary completion: Sep 30, 2003 Completion: Sep 30, 2003

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00671567, this PHASE3 trial focuses on Chronic Insomnia and remains completed. Sponsored by Takeda, it has been updated 7 times since 2002, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Dec 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Takeda

Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Altoona, United States , Anaheim, United States , Arlington Heights, United States , Atlanta, United States , Beachwood, United States , Bethesda, United States , Birmingham, United States , Blairsville, United States , Brockton, United States and 60 more locations