Clinical trial NCT00666575: A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transient Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 2105
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* Subjects \>/= 12 years of age who reported occasional sleeplessness in month prior to screening

Exclusion Criteria:

* Females who were pregnant or breastfeeding

Primary outcomes:
measure: Adverse Events
timeFrame: Day 45
Secondary outcomes:
measure: Pulse and Blood Pressure
timeFrame: Day 45
measure: Subjective proportion of nights having difficulty sleeping
timeFrame: Day 45
measure: Subjective Sleep Latency
timeFrame: Day 45
measure: Subjective Wake After Sleep Onset
timeFrame: Day 45
measure: Subjective Number of Awakenings
timeFrame: Day 45
measure: Subjective Total Sleep Time
timeFrame: Day 45
measure: Subjective Assessment of Sleep Quality
timeFrame: Day 45
measure: Subjective Assessment of Ease of Awakening
timeFrame: Day 45
measure: Subject Global Evaluation
timeFrame: Day 45
measure: Pittsburg Sleep Quality Index
timeFrame: Day 45
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Santa Fe
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: