Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00163046
Previous Study | Return to List | Next Study

A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00163046
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 24, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date April 24, 2008
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO) [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00163046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
  • PSG WAPSO [ Time Frame: Day 28 ]
  • PSG Latency to Persistent Sleep (LPS) [ Time Frame: Days 1 and 28 ]
  • PSG Sleep Onset Latency (SOL) [ Time Frame: Days 1 and 28 ]
  • PSG Number of Awakenings (NAW) [ Time Frame: Days 1 and 28 ]
  • PSG Wake after Sleep Onset (WASO) [ Time Frame: Days 1 and 28 ]
  • PSG Total Wake Time (TWT) plus Stage 1 Sleep [ Time Frame: Days 1 and 28 ]
  • PSG Wake Time During Sleep (WTDS) [ Time Frame: Days 1 and 28 ]
  • PSG Total Sleep Time (TST) [ Time Frame: Days 1 and 28 ]
  • PSG Sleep Efficiency (SE) [ Time Frame: Days 1 and 28 ]
  • PSG Percent of Stages 1, 2, 3, 4 and REM sleep [ Time Frame: Days 1 and 28 ]
  • PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined) [ Time Frame: Days 1 and 28 ]
  • Subjective SL [ Time Frame: Days 1 and 28 ]
  • Subjective NA [ Time Frame: Days 1 and 28 ]
  • Subjective WASO [ Time Frame: Days 1 and 28 ]
  • Subjective TST [ Time Frame: Days 1 and 28 ]
  • Subjective ASR [ Time Frame: Days 1 and 28 ]
  • Subjective ASQ [ Time Frame: Days 1 and 28 ]
  • Karolinska Sleep Diary (KSD)-Sleep Quality Index [ Time Frame: Days 1 and 28 ]
  • KSD individual scores [ Time Frame: Days 1 and 28 ]
  • Vital signs [ Time Frame: Days 1 and 28 ]
  • Adverse events [ Time Frame: Through Day 32 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-Day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance
Brief Summary The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Transient Insomnia
Intervention  ICMJE
  • Drug: Gabapentin
    Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
  • Drug: Placebo
    Matched placebo 30 minutes prior to bedtime for 28 days
Study Arms  ICMJE
  • Experimental: Gabapentin
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Furey SA, Hull SG, Leibowitz MT, Jayawardena S, Roth T. A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1101-9. doi: 10.5664/jcsm.4110.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2008)
256
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
200
Actual Study Completion Date  ICMJE April 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older with occasional sleeplessness in the month prior to screening

Exclusion Criteria:

  • Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
  • Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163046
Other Study ID Numbers  ICMJE A9451155
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP