A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
NCT ID: NCT00386334
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
388 participants
INTERVENTIONAL
2006-10-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Week -2 to day 0 single blind one tablet placebo in the evening. Double blind period: Day 1 to Week 12 double blind one tablet placebo in the evening. Follow up period: two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.
Placebo
Tablet one per day in the evening.
Eszopiclone
Week -2 to day 0 single blind one tablet placebo in evening. Double Blind period: Day 1 to Week 12 double blind one tablet 2 mg of eszopiclone in evening. Follow up period consists of two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.
Eszopiclone
2 mg tablet once per day in the evening
Placebo
Tablet one per day in the evening.
Interventions
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Eszopiclone
2 mg tablet once per day in the evening
Placebo
Tablet one per day in the evening.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
65 Years
85 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, CNS
Role: STUDY_CHAIR
Sumitomo Pharma America, Inc.
Locations
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Birmingham, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Irvine, California, United States
La Mesa, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Atlanta, Florida, United States
Clearwater, Florida, United States
Coral Springs, Florida, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Gables, Florida, United States
Jupiter, Florida, United States
Maitland, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
St. Petersburg, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
Stockbridge, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Vernon Hills, Illinois, United States
Evansville, Indiana, United States
Overland Park, Kansas, United States
Prairie Village, Kansas, United States
Crestview Hills, Kentucky, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Braintree, Massachusetts, United States
Newton, Massachusetts, United States
Florissant, Missouri, United States
Hamilton, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Cary, North Carolina, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Mogadore, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Scotland, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson Pharmaceutical Research
Anderson, South Carolina, United States
Anderson, South Carolina, United States
Simpsonville, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Countries
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References
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Ancoli-Israel S, Krystal AD, McCall WV, Schaefer K, Wilson A, Claus R, Rubens R, Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. Sleep. 2010 Feb;33(2):225-34. doi: 10.1093/sleep/33.2.225.
Other Identifiers
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190-904
Identifier Type: -
Identifier Source: org_study_id
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