A Study of Zolpidem Tartrate Lozenge in Adult Patients With Insomnia
Information source: TransOral Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Initiation and Maintenance Disorders
Intervention: Zolpidem Tartrate Lozenge (Intermezzo) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: TransOral Pharmaceuticals Official(s) and/or principal investigator(s):
Andrew Krystal, MD, Principal Investigator, Affiliation: Clincal Neurophysiology Training Program, Duke University
Thomas Roth, PhD, Principal Investigator, Affiliation: Sleep Disorders and Research Center, Henry Ford Hospital
Summary
The purpose of the study is to evaluate sleep onset following administration of Zolpidem
Tartrate Lozenge (Intermezzo) versus placebo in adult insomnia patients.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults with history of sleeplessness
Exclusion Criteria:
- Allergic to investigational drug
- Any conditions and medications that may interfere with study drug evaluation
Locations and Contacts
TransOral Investigational Site, Durham, North Carolina 27710, United States
Additional Information
Last updated: April 1, 2008
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