A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness
1 other identifier
interventional
1,254
1 country
35
Brief Summary
The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2006
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedFebruary 2, 2021
April 1, 2011
April 1, 2008
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
Throughout Day 90
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
Throughout Day 90
Secondary Outcomes (1)
Adverse events
Duration of study
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age of 18 years or older with symptoms of sleeplessness
- Provided informed consent
You may not qualify if:
- Contraindications to use of gabapentin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Pfizer Investigational Site
Anaheim, California, 92801, United States
Pfizer Investigational Site
Bonita, California, 91902, United States
Pfizer Investigational Site
Fallbrook, California, 92028, United States
Pfizer Investigational Site
Hacienda Heights, California, 91746, United States
Pfizer Investigational Site
La Mesa, California, 91942, United States
Pfizer Investigational Site
Oceanside, California, 92054, United States
Pfizer Investigational Site
Orange, California, 92866, United States
Pfizer Investigational Site
San Dimas, California, 91773, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33026, United States
Pfizer Investigational Site
Weston, Florida, 33326, United States
Pfizer Investigational Site
Baltimore, Maryland, 21228, United States
Pfizer Investigational Site
Elk River, Minnesota, 55330, United States
Pfizer Investigational Site
Northfield, Minnesota, 55057, United States
Pfizer Investigational Site
Red Wing, Minnesota, 55066, United States
Pfizer Investigational Site
Saint Louis Park, Minnesota, 55426, United States
Pfizer Investigational Site
Holly Springs, Mississippi, 38625, United States
Pfizer Investigational Site
Belton, Missouri, 64012, United States
Pfizer Investigational Site
Independence, Missouri, 64054, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87104, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87110, United States
Pfizer Investigational Site
Taos, New Mexico, 87571, United States
Pfizer Investigational Site
Cary, North Carolina, 27513, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27514, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27606, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27612, United States
Pfizer Investigational Site
Houston, Texas, 77088, United States
Pfizer Investigational Site
Pearland, Texas, 77581, United States
Pfizer Investigational Site
Bountiful, Utah, 84010, United States
Pfizer Investigational Site
Ogden, Utah, 84401, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84121, United States
Pfizer Investigational Site
Syracuse, Utah, 84075, United States
Pfizer Investigational Site
West Valley City, Utah, 84120, United States
Pfizer Investigational Site
Falls Church, Virginia, 22041, United States
Pfizer Investigational Site
Richmond, Virginia, 23233, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 16, 2008
Study Start
August 1, 2006
Study Completion
January 1, 2007
Last Updated
February 2, 2021
Record last verified: 2011-04