Status:
COMPLETED
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Lead Sponsor:
Transcept Pharmaceuticals
Conditions:
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
Eligibility Criteria
Inclusion
- 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 kg/m\^2
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00380081
Start Date
April 1 2006
End Date
July 1 2006
Last Update
February 14 2012
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