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

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 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 Gabapentin enacarbil

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:	1254
Study Start Date:	August 2006
Study Completion Date:	January 2007

Arms	Assigned Interventions
Experimental: A	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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00659100 History of Changes
Other Study ID Numbers:	A9451159
Study First Received:	April 1, 2008
Last Updated:	April 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 24, 2012