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

Purpose

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.

Condition	Intervention	Phase
Transient Insomnia	Drug: Gabapentin	Phase III

MedlinePlus related topics:

Over-the-Counter Medicines

ChemIDplus related topics:

Gabapentin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications) [ Time Frame: Throughout Day 90 ] [ Designated as safety issue: Yes ]
Subject compliance with directions for use (number of capsules per dose and the number of doses per day) [ Time Frame: Throughout Day 90 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment:	1257
Study Start Date:	August 2006
Study Completion Date:	January 2007

Arms	Assigned Interventions
A: Experimental	Drug: Gabapentin Gabapentin 50 mg oral capsule 30 minutes before bedtime

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contraindications to use of gabapentin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659100

Show 35 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9451159
First Received:	April 1, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00659100
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders

Excitatory Amino Acids

Gabapentin

Mental Disorders

Dyssomnias

Sleep Disorders

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antiparkinson Agents

Calcium Channel Blockers

Excitatory Amino Acid Agents

Cardiovascular Agents

Antimanic Agents

Pharmacologic Actions

Membrane Transport Modulators

Sensory System Agents

Therapeutic Uses

Anti-Anxiety Agents

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00659100