A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment

Condition(s) targeted: Transient Insomnia

Intervention: Gabapentin (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 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.

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 design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome:

Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)

Subject compliance with directions for use (number of capsules per dose and the number of doses per day)

Secondary outcome: Adverse events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age of 18 years or older with symptoms of sleeplessness

- Provided informed consent

Exclusion Criteria:

- Contraindications to use of gabapentin

Pfizer Investigational Site, Hacienda Heights, California 91746, United States

Pfizer Investigational Site, Orange, California 92866, United States

Pfizer Investigational Site, San Dimas, California 91773, United States

Pfizer Investigational Site, Anaheim, California 92801, United States

Pfizer Investigational Site, Oceanside, California 92054, United States

Pfizer Investigational Site, La Mesa, California 91942, United States

Pfizer Investigational Site, Fallbrook, California 92028, United States

Pfizer Investigational Site, Bonita, California 91902, United States

Pfizer Investigational Site, Weston, Florida 33326, United States

Pfizer Investigational Site, Pembroke Pines, Florida 33026, United States

Pfizer Investigational Site, Baltimore, Maryland 21228, United States

Pfizer Investigational Site, Northfield, Minnesota 55057, United States

Pfizer Investigational Site, St. Louis Park, Minnesota 55426, United States

Pfizer Investigational Site, Red Wing, Minnesota 55066, United States

Pfizer Investigational Site, Elk River, Minnesota 55330, 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, Taos, New Mexico 87571, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87110, United States

Pfizer Investigational Site, Raleigh, North Carolina 27612, United States

Pfizer Investigational Site, Chapel Hill, North Carolina 27514, United States

Pfizer Investigational Site, Cary, North Carolina 27513, United States

Pfizer Investigational Site, Raleigh, North Carolina 27609, United States

Pfizer Investigational Site, Raleigh, North Carolina 27606, United States

Pfizer Investigational Site, Pearland, Texas 77581, United States

Pfizer Investigational Site, Houston, Texas 77088, 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, West Valley City, Utah 84120, United States

Pfizer Investigational Site, Syracuse, Utah 84075, United States

Pfizer Investigational Site, Falls Church, Virginia 22041, United States

Pfizer Investigational Site, Richmond, Virginia 23233, United States

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

Link to ClinicalStudyResults.org Posting

Starting date: August 2006
Ending date: January 2007
Last updated: May 5, 2008