Who is sponsoring NCT00492232?

NCT00492232 is sponsored by Takeda.

What condition does NCT00492232 study?

NCT00492232 studies Chronic Insomnia.

What drugs are being tested in NCT00492232?

Interventions: Ramelteon and zolpidem, Placebo and zolpidem.

What is the status of NCT00492232?

NCT00492232 is currently COMPLETED.

Last reviewed 2010-07-13 · How we verify

Randomized, Double Blind, Placebo-Controlled Study to Assess Whether the Administration of Ramelteon Could Facilitate the Discontinuation of Zolpidem (Ambien®) ≥10 mg Therapy in Subjects With Chronic Insomnia

NCT00492232 Phase 4 COMPLETED Results posted

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

Details

Lead sponsor	Takeda
Phase	Phase 4
Status	COMPLETED
Enrolment	135
Start date	2007-04
Completion	2008-05

Conditions

Chronic Insomnia

Interventions

Ramelteon and zolpidem
Placebo and zolpidem

Primary outcomes

Percentage of Participants Who Discontinued Zolpidem Therapy — Week 10
Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.

Countries

United States