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

This study has been completed.

First Received: April 1, 2008 Last Updated: May 5, 2008 History of Changes

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Over-the-Counter Medicines

Drug Information available for: Gabapentin

U.S. FDA Resources

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

Additional 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

No publications provided

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

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sleep Disorders
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Sleep Disorders, Intrinsic
Membrane Transport Modulators
Sensory System Agents
Mental Disorders

Therapeutic Uses
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Nervous System Diseases
Dyssomnias
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2010