Status:
COMPLETED
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Transient Insomnia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.
Eligibility Criteria
Inclusion
- Aged \>/= 18 years who reported occasional sleeplessness in the month prior to screening
- Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening
Exclusion
- Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT00674752
Start Date
March 1 2006
End Date
August 1 2006
Last Update
February 2 2021
Active Locations (4)
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1
Pfizer Investigational Site
Miami, Florida, United States, 33143
2
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
3
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
4
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45227