Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia
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
2 other identifiers
interventional
135
1 country
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2007
Shorter than P25 for phase_4
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
July 17, 2009
CompletedJuly 20, 2010
July 1, 2010
11 months
June 25, 2007
May 28, 2009
July 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Discontinued Zolpidem Therapy
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.
Week 10
Secondary Outcomes (13)
Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2
Baseline and Weeks 1-2
Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4
Baseline and Weeks 3-4
Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6
Baseline and Weeks 5-6
Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8
Baseline and Weeks 7-8
Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10
Baseline and Weeks 9-10
- +8 more secondary outcomes
Study Arms (2)
Ramelteon 8 mg QD and current Zolpidem therapy
EXPERIMENTALZolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.
Placebo QD and current Zolpidem therapy
PLACEBO COMPARATORZolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.
Interventions
Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
Eligibility Criteria
You may qualify if:
- Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times per week.
- Has been prescribed zolpidem for difficulty in initiating sleep.
- Must report chronic use of zolpidem greater than or equal to10 mg therapy for a minimum of 3 months prior to entry into Period 1 of the study.
- Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7 days each week of the 4 weeks immediately prior to entry into the double blind phase, Period 2.
- Expressed a willingness to discontinue zolpidem therapy.
- Habitual bedtime is between 9:00 PM and 1:00 AM based on sleep history.
- Negative test result for hepatitis B surface antigen and hepatitis C virus antibody.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
You may not qualify if:
- Known hypersensitivity to ramelteon, zolpidem, or melatonin.
- Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication.
- Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication.
- 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.
- History of drug addiction or drug abuse within the past 12 months.
- History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes more than 2 alcoholic drinks per day.
- Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of run-in study medication.
- Body mass index of less than 18 or greater than 34 (weight /height2).
- Any clinically important abnormal finding as documented by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- Positive hepatitis panel.
- Known history of human immunodeficiency virus.
- Any additional conditions(s) that in the investigator's opinion would affect:
- sleep/wake function
- prohibit the subject from completing the study
- indicate that continuation in the study would not be in the best interests of the subject.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (41)
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Redlands, California, United States
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San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Santa Monica, California, United States
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Denver, Colorado, United States
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Clearwater, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Kissimmee, Florida, United States
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Naples, Florida, United States
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Pembroke Pines, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Austell, Georgia, United States
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Boise, Idaho, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Chevy Chase, Maryland, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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New York, New York, United States
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West Seneca, New York, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Fayetteville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Angelo, Texas, United States
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San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda Global Research & Development Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 27, 2007
Study Start
April 1, 2007
Primary Completion
March 1, 2008
Study Completion
May 1, 2008
Last Updated
July 20, 2010
Results First Posted
July 17, 2009
Record last verified: 2010-07