Status:
COMPLETED
A Polysomnographic Study of Single-Dose 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 assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
Eligibility Criteria
Inclusion
- Aged \>/= 18 years
- 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)
- Recreational drug use within past 30 days
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00666770
Start Date
October 1 2004
End Date
November 1 2004
Last Update
February 2 2021
Active Locations (5)
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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, 66211
4
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212