Clinical trial NCT00659100: A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transient Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 1254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older with symptoms of sleeplessness
* Provided informed consent

Exclusion Criteria:

* Contraindications to use of gabapentin

Primary outcomes:
measure: Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
timeFrame: Throughout Day 90
measure: Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
timeFrame: Throughout Day 90
Secondary outcomes:
measure: Adverse events
timeFrame: Duration of study
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Bonita
country: United States
facility: Pfizer Investigational Site
state: California
city: Fallbrook
country: United States
facility: Pfizer Investigational Site
state: California
city: Hacienda Heights
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: San Dimas
country: United States
facility: Pfizer Investigational Site
state: California
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Weston
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Elk River
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Northfield
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Red Wing
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Saint Louis Park
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Holly Springs
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Belton
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Independence
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Taos
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Pearland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bountiful
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Ogden
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Valley City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Falls Church
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: