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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00666939
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 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 Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance

Resource links provided by NLM:


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
Experimental: A Drug: Gabapentin
Gabapentin 100 mg oral capsule 30 minutes prior to bedtime
Experimental: B Drug: Gabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Placebo Comparator: C 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00666939     History of Changes
Other Study ID Numbers: A9451141
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 September 11, 2014