Status:
COMPLETED
A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
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 to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia indu...
Eligibility Criteria
Inclusion
- 18 years of age or older with occasional sleeplessness in the month prior to screening
Exclusion
- Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
- Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00163046
Start Date
October 1 2005
End Date
April 1 2006
Last Update
February 2 2021
Active Locations (3)
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1
Pfizer Investigational Site
Glendale, California, United States, 91206
2
Pfizer Investigational Site
San Diego, California, United States, 92123
3
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212