A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
NCT ID: NCT00466193
Last Updated: 2012-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
295 participants
INTERVENTIONAL
2007-05-31
2007-11-30
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
DOUBLE
Study Groups
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Zolpidem 3.5mg
zolpidem tartrate sublingual tablet
3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Placebo
Placebo
Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Interventions
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zolpidem tartrate sublingual tablet
3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Placebo
Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any conditions and medications that may interfere with study drug evaluation
18 Years
64 Years
ALL
No
Sponsors
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Transcept Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Krystal, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Neurophysiology Training Program, Duke University
Thomas Roth, PhD
Role: PRINCIPAL_INVESTIGATOR
Sleep Disorders and Research Center, Henry Ford Hospital
Locations
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Transcept Investigational Site
Durham, North Carolina, United States
Countries
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Other Identifiers
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ZI-12
Identifier Type: -
Identifier Source: org_study_id
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