A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness

Condition(s) targeted: Transient Insomnia

Intervention: Gabapentin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Adverse Events

Secondary outcome:

Pulse and Blood Pressure

Subjective proportion of nights having difficulty sleeping

Subjective Sleep Latency

Subjective Wake After Sleep Onset

Subjective Number of Awakenings

Subjective Total Sleep Time

Subjective Assessment of Sleep Quality

Subjective Assessment of Ease of Awakening

Subject Global Evaluation

Pittsburg Sleep Quality Index

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer Investigational Site, Mobile, Alabama 36608, United States

Pfizer Investigational Site, Phoenix, Arizona 85018, United States

Pfizer Investigational Site, Beverly Hills, California 90211, United States

Pfizer Investigational Site, San Francisco, California 94102, United States

Pfizer Investigational Site, West Palm Beach, Florida 33409, United States

Pfizer Investigational Site, New Port Richey, Florida 34652, United States

Pfizer Investigational Site, Pembroke Pines, Florida 33024, United States

Pfizer Investigational Site, Deland, Florida 32720, United States

Pfizer Investigational Site, Clearwater, Florida 33765, United States

Pfizer Investigational Site, Atlanta, Georgia 30328, United States

Pfizer Investigational Site, Boise, Idaho 83704, United States

Pfizer Investigational Site, Boise, Idaho 83712, United States

Pfizer Investigational Site, Indianapolis, Indiana 46250, United States

Pfizer Investigational Site, Las Vegas, Nevada 89104, United States

Pfizer Investigational Site, Las Vegas, Nevada 89128, United States

Pfizer Investigational Site, Santa Fe, New Mexico 87505, United States

Pfizer Investigational Site, Nashville, Tennessee 37203, United States

Pfizer Investigational Site, Austin, Texas 78705, United States

Pfizer Investigational Site, Fort Worth, Texas 76135, United States

Pfizer Investigational Site, San Antonio, Texas 78205, United States

Pfizer Investigational Site, SAN ANTONIO, Texas 78229, United States

Pfizer Investigational Site, Salt Lake City, Utah 84102, United States

Pfizer Investigational Site, West Jordan, Utah 84088, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: December 2004
Ending date: May 2005
Last updated: April 23, 2008