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A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00674752
First received: May 6, 2008
Last updated: April 22, 2011
Last verified: April 2011
History of Changes
  Purpose

The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.


Condition Intervention Phase
Transient Insomnia
 Drug: Gabapentin
Drug: Placebo
 Phase 3

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, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Wake after sleep onset as measured by polysomnography (PSG) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSG Latency to Persistent Sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Wake Time During Sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG WASO [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Sleep Onset Latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Vital signs [ 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 ]
  • PSG NA [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Hour +13 ] [ Designated as safety issue: Yes ]
  • PSG Total wake time plus Stage 1 sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG TST [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Sleep Efficiency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Percent of Stages 1, 2, 3, 4 and REM sleep [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • PSG Percent slow wave sleep (Stages 3&4 combined) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Sleep Latency [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Number of Awakenings (NA) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Wake After Sleep Onset (WASO) [ Time Frame: Hour +8 ] [ Designated as safety issue: No ]
  • subjective Total Sleep Time (TST) [ 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 ]

Enrollment: 377
Study Start Date: March 2006
Study Completion Date: August 2006
Arms Assigned Interventions
Experimental: A Drug: Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Experimental: B Drug: Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Placebo Comparator: C Drug: Placebo
Matched placebo oral capsule 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 who reported occasional sleeplessness in the month prior to screening
  • 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)
  • Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674752

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33143
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45227
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: NCT00674752     History of Changes
Other Study ID Numbers: A9451157
Study First Received: May 6, 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 23, 2013