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A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Primary Purpose

Transient Insomnia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Gabapentin
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transient Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Wake after sleep onset as measured by polysomnography (PSG)

Secondary Outcome Measures

PSG Latency to Persistent Sleep
PSG Wake Time During Sleep
PSG WASO
PSG Sleep Onset Latency
Vital signs
Karolinska Sleep Diary-Sleep (KSD) Quality Index
KSD individual scores
PSG NA
Adverse events
PSG Total wake time plus Stage 1 sleep
PSG TST
PSG Sleep Efficiency
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
PSG Percent slow wave sleep (Stages 3&4 combined)
subjective Sleep Latency
subjective Number of Awakenings (NA)
subjective Wake After Sleep Onset (WASO)
subjective Total Sleep Time (TST)
subjective Assessment of Sleep Refreshment
subjective Assessment of Sleep Quality

Full Information

First Posted
May 6, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00674752
Brief Title
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo oral capsule 30 minutes prior to bedtime
Primary Outcome Measure Information:
Title
Wake after sleep onset as measured by polysomnography (PSG)
Time Frame
Hour +8
Secondary Outcome Measure Information:
Title
PSG Latency to Persistent Sleep
Time Frame
Hour +8
Title
PSG Wake Time During Sleep
Time Frame
Hour +8
Title
PSG WASO
Time Frame
Hour +8
Title
PSG Sleep Onset Latency
Time Frame
Hour +8
Title
Vital signs
Time Frame
Hour +8
Title
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Time Frame
Hour +8
Title
KSD individual scores
Time Frame
Hour +8
Title
PSG NA
Time Frame
Hour +8
Title
Adverse events
Time Frame
Hour +13
Title
PSG Total wake time plus Stage 1 sleep
Time Frame
Hour +8
Title
PSG TST
Time Frame
Hour +8
Title
PSG Sleep Efficiency
Time Frame
Hour +8
Title
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Time Frame
Hour +8
Title
PSG Percent slow wave sleep (Stages 3&4 combined)
Time Frame
Hour +8
Title
subjective Sleep Latency
Time Frame
Hour +8
Title
subjective Number of Awakenings (NA)
Time Frame
Hour +8
Title
subjective Wake After Sleep Onset (WASO)
Time Frame
Hour +8
Title
subjective Total Sleep Time (TST)
Time Frame
Hour +8
Title
subjective Assessment of Sleep Refreshment
Time Frame
Hour +8
Title
subjective Assessment of Sleep Quality
Time Frame
Hour +8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25317090
Citation
Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451157&StudyName=A%20Polysomnographic%20Study%20Of%20Single-Dose%20Gabapentin%20In%20Transient%20Insomnia%20
Description
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A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

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