A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00666939

Purpose

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.

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

Drug Information available for: Gabapentin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance

Further study details as provided by Pfizer:

Primary Outcome Measures:

Subjective sleep latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stanford Sleepiness Scale [ Time Frame: Hour +13 ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Hour +8 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Hour +13 ] [ Designated as safety issue: Yes ]
Subjective number of awakenings [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective wake after sleep onset [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective total sleep time [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective assessment of sleep refreshment [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Subjective assessment of sleep quality [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Karolinska Sleep Diary-Sleep (KSD) Quality Index [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
KSD individual scores [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Digit Symbol Substitution Test [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]

Enrollment:	773
Study Start Date:	October 2004
Study Completion Date:	January 2005

Arms	Assigned Interventions
A: Experimental	Drug: Gabapentin Gabapentin 100 mg oral capsule 30 minutes prior to bedtime
B: Experimental	Drug: Gabapentin Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
C: Placebo Comparator	Drug: Placebo Matched placebo 30 minutes prior to bedtime

Eligibility

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

Criteria

Inclusion Criteria:

Aged >/= 18 years
Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening

Exclusion Criteria:

Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
Recreational drug use within past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666939

Locations

United States, California
Pfizer Investigational Site
San Diego, California, United States, 92108
United States, Florida
Pfizer Investigational Site
Ocala, Florida, United States, 34471
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
United States, Louisiana
Pfizer Investigational Site
Metairie, Louisiana, United States, 70001
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10025
Pfizer Investigational Site
Thornwood, New York, United States, 10594
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Pfizer Investigational Site
Johnstown, Pennsylvania, United States, 15904

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:	A9451141
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00666939
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Excitatory Amino Acids
Calcium, Dietary
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 January 16, 2009