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A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
This study has been completed.
First Received: May 6, 2008   Last Updated: May 8, 2008   History of Changes
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00674752
  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 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, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance

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: 375
Study Start Date: March 2006
Study Completion Date: August 2006
Arms Assigned Interventions
A: Experimental Drug: Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
B: Experimental Drug: Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
C: Placebo Comparator 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
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: A9451157
Study First Received: May 6, 2008
Last Updated: May 8, 2008
ClinicalTrials.gov Identifier: NCT00674752     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Excitatory Amino Acids
Neurotransmitter Agents
Tranquilizing Agents
Gabapentin
Psychotropic Drugs
Central Nervous System Depressants
Sleep Disorders
Dyssomnias
Calcium Channel Blockers
 Cardiovascular Agents
Antimanic Agents
Sleep Disorders, Intrinsic
Calcium, Dietary
Mental Disorders
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Anticonvulsants

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 May 07, 2009



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