Status:
COMPLETED
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Transient Insomnia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
Eligibility Criteria
Inclusion
- Subjects \>/= 12 years of age who reported occasional sleeplessness in month prior to screening
Exclusion
- Females who were pregnant or breastfeeding
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2005
Estimated Enrollment :
2105 Patients enrolled
Trial Details
Trial ID
NCT00666575
Start Date
December 1 2004
End Date
May 1 2005
Last Update
February 2 2021
Active Locations (23)
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1
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85018
3
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
4
Pfizer Investigational Site
San Francisco, California, United States, 94102