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Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

NCT00492232 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2010-07-20

Study results available
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Summary

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

Conditions

  • Chronic Insomnia

Interventions

DRUG

Ramelteon and zolpidem

Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.

DRUG

Placebo and zolpidem

Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda Global Research & Development Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-03-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00492232 on ClinicalTrials.gov