A Study to Assess Facilitation of the Discontinuation of Zolpidem by Ramelteon Administration in Subjects With Chronic Insomnia
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Insomnia
Intervention: Ramelteon (Drug); Placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Sherry Weigand, MD, PhD, Study Director, Affiliation: Takeda Global Research & Development Center
Summary
This study is designed to assess whether administration of ramelteon will facilitate the
discontinuation of zolpidem in subjects with chronic insomnia. Subjects will receive placebo
or ramelteon, in addition to decreasing doses of zolpidem, over the course of the study. At
the end of the study, ramelteon will be compared with placebo with respect to the number of
subjects who no longer require zolpidem therapy.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess whether the administration of ramelteon nightly will facilitate the discontinuation of long-term use of zolpidem therapy in subjects with chronic insomnia.
Secondary outcome: To identify the method of discontinuing zolpidem use, based on subject's voluntary choice which is most likely to lead to successful mean weekly dose reduction/cessation of zolpidem therapy when using ramelteon.
Detailed description:
This is a phase 4, double-blind, randomized, placebo controlled study to assess whether
administration of ramelteon will facilitate the discontinuation of zolpidem (Ambien®) therapy
in subjects with chronic insomnia. For 4 weeks, subjects will take nightly single-blind
medication, either zolpidem or study medication. For the next 10 weeks, subjects will take a
nightly dose of double-blind study medication (ramelteon 8 mg or placebo). During this time,
subjects will continue taking zolpidem, however the amount will be gradually reduced over the
10 week period. If after 10 weeks subjects are able to reduce their zolpidem by at least
half (50%), they will continue for 2 additional weeks; during this time 8 mg of ramelteon
will be administered once a day for 2 weeks. At the end of the study, ramelteon will be
compared with placebo with respect to the number of subjects who no longer require zolpidem
therapy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female 18 years of age or older with chronic insomnia
- The subject has been prescribed zolpidem for difficulty in initiating sleep
- The subject must report chronic use of zolpidem ≥ 10mg therapy for a minimum of 3
months prior to entry into study, and subjects have expressed a willingness to
discontinue their zolpidem therapy
- The subject's habitual bedtime is between 9 PM and 1 AM
- The subject is fluent in English (speaking, reading, writing)—for purpose of data
collection
Exclusion Criteria:
- The subject has a known hypersensitivity to ramelteon or zolpidem or melatonin
- The subject has participated in any other investigational study and/or taken any
investigational drug within 30 days
- The subject has sleep schedule changes required by employment (eg, shift worker)
within 3 months prior to the start of the study
- The subject has a history of fibromyalgia, history of seizures, sleep apnea, restless
leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease,
schizophrenia, bipolar disorder, mental retardation, or cognitive disorder
- The subject has current significant disease, not currently controlled and stable with
protocol-allowed medication
- Female subjects who are pregnant and/or lactating
Locations and Contacts
Hot Springs, Arkansas, United States
San Francisco, California, United States
Redlands, California, United States
Fountain Valley, California, United States
Anaheim, California, United States
San Diego, California, United States
Los Angeles, California, United States
Santa Monica, California, United States
La Mesa, California, United States
Denver, Colorado, United States
Hollywood, Florida, United States
Kissimmee, Florida, United States
Naples, Florida, United States
Winter Park, Florida, United States
Clearwater, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Austell, Georgia, United States
Boise, Idaho, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Chevy Chase, Maryland, United States
St. Louis, Missouri, United States
Lincoln, Nebraska, United States
West Seneca, New York, United States
New York, New York, United States
Wilmington, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Greer, South Carolina, United States
Fayetteville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Austin, Texas, United States
San Angelo, Texas, United States
San Antonio, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Additional Information
Starting date: April 2007
Ending date: June 2008
Last updated: June 10, 2008
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