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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00667108

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

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 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance

Resource links provided by NLM:

Drug Information available for: Gabapentin

U.S. FDA Resources

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:

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 ]
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 ]

Enrollment:	784
Study Start Date:	October 2004
Study Completion Date:	January 2005

Arms	Assigned Interventions
Gabapentin 250 mg: Experimental	Drug: Gabapentin Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Gabapentin 500 mg: Experimental	Drug: Gabapentin Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Placebo: 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: NCT00667108

Locations

United States, California
Pfizer Investigational Site
San Diego, California, United States, 92121
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83704
United States, New Jersey
Pfizer Investigational Site
Mt. Laurel, New Jersey, United States, 08054
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Pfizer Investigational Site
Spartanburg, South Carolina, United States, 29307
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75235

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:	A9451140
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00667108 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 08, 2010