A Study of TransOral Zolpidem 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: Insomnia
Intervention: Zolpidem (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: TransOral Pharmaceuticals Official(s) and/or principal investigator(s):
Thomas Roth, PhD, Principal Investigator, Affiliation: Henry Ford Hospital , Sleep Disorders and Research Center
Martin Scharf, PhD, Principal Investigator, Affiliation: Tri-State Sleep Disorders Center
Summary
The purpose of this study is to evaluate sleep onset following administration of TransOral
zolpidem versus placebo in adult insomnia patients.
Clinical Details
Study design: Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Sleep onset
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Insomnia as defined by DSM-IV criteria and supported by subject diary
- Male or female between the ages of 18-64 years
- Body mass index (BMI) between 18-34
- Females of childbearing potential must use a medically acceptable method of
contraception
- Capable of understanding and willing to comply with study procedures and has provided
informed consent
Exclusion Criteria:
- Females who are pregnant, breast-feeding or have a positive pregnancy test
- Any circadian rhythm disorder including planned travel across several time zones
during the study period
- Known hypersensitivity to Zolpidem
- Has performed regular shift work with the past several months prior to screening
- An acute clinically significant illness or surgery as determined by the PI within 30
days of screening
- Patients that have used any central nervous system (CNS) medication or other
medication known to impact the sleep/wake cycle
- A history of psychiatric disorder as defined by DSM-IV
- A history of drug addiction or alcohol abuse
- Any current significant disease, unless adequately controlled with a protocol allowed
medication
- Known history of HIV or Hepatitis B or C
- Patients who have received an investigational drug within several months of screening
Locations and Contacts
Additional Information
Last updated: April 1, 2008
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