The purpose of the study is to evaluate sleep onset following administration of Zolpidem Tartrate Lozenge (Intermezzo) versus placebo in adult insomnia patients...
Date First Received: April 24, 2007
Last Updated: April 1, 2008
Verified by: TransOral Pharmaceuticals, April 2008
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Completed
Estimated Enrollment: 320
Brief Summary
Condition Keyword(s):
Intervention(s):
The purpose of the study is to evaluate sleep onset following administration of Zolpidem Tartrate Lozenge (Intermezzo) versus placebo in adult insomnia patients.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Zolpidem Tartrate Lozenge (Intermezzo)
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adults with history of sleeplessness
Exclusion Criteria:
- Allergic to investigational drug
- Any conditions and medications that may interfere with study drug evaluation
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 64 Years
Clinical Trial Sponsor Information
Lead Sponsor: TransOral Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Andrew Krystal, MD Principal Investigator Clincal Neurophysiology Training Program, Duke University
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00466193
Study ID Number: ZI-12
ClinicalTrials.gov Identifier: NCT00466193
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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