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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00666575

Purpose

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

Condition	Intervention	Phase
Transient Insomnia	Drug: Gabapentin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

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:

Adverse Events [ Time Frame: Day 45 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pulse and Blood Pressure [ Time Frame: Day 45 ] [ Designated as safety issue: Yes ]
Subjective proportion of nights having difficulty sleeping [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Subjective Sleep Latency [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Subjective Wake After Sleep Onset [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Subjective Number of Awakenings [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Subjective Total Sleep Time [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Subjective Assessment of Sleep Quality [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Subjective Assessment of Ease of Awakening [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Subject Global Evaluation [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
Pittsburg Sleep Quality Index [ Time Frame: Day 45 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2105
Study Start Date:	December 2004
Study Completion Date:	May 2005

Arms	Assigned Interventions
Experimental: Gabapentin	Drug: Gabapentin Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days
Placebo Comparator: Placebo	Drug: Placebo Matched placebo oral capsule 30 minutes prior to bedtime for 28 days

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666575

Locations

United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85018
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
Pfizer Investigational Site
San Francisco, California, United States, 94102
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33765
Pfizer Investigational Site
Deland, Florida, United States, 32720
Pfizer Investigational Site
New Port Richey, Florida, United States, 34652
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33024
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83704
Pfizer Investigational Site
Boise, Idaho, United States, 83712
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89104
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Mexico
Pfizer Investigational Site
Santa Fe, New Mexico, United States, 87505
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Fort Worth, Texas, United States, 76135
Pfizer Investigational Site
San Antonio, Texas, United States, 78205
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
Pfizer Investigational Site
West Jordan, Utah, United States, 84088

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:	NCT00666575 History of Changes
Other Study ID Numbers:	A9451146
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
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 February 09, 2012