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

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
  • 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

Sites / Locations

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

Gabapentin 250 mg

Gabapentin 500 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Subjective sleep latency

Secondary Outcome Measures

Subjective assessment of sleep refreshment
Subjective assessment of sleep quality
Karolinska Sleep Diary-Sleep (KSD) Quality Index
KSD individual scores
Digit Symbol Substitution Test
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
Stanford Sleepiness Scale
Vital signs
Adverse events
Subjective number of awakenings
Subjective wake after sleep onset
Subjective total sleep time

Full Information

First Posted
April 23, 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
NCT00667108
Brief Title
A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Official Title
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter 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 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (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 as compared to placebo on sleep, using subjective sleep measurements, in subjects with 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
784 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin 250 mg
Arm Type
Experimental
Arm Title
Gabapentin 500 mg
Arm Type
Experimental
Arm Title
Placebo
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 30 minutes prior to bedtime
Primary Outcome Measure Information:
Title
Subjective sleep latency
Time Frame
Hour +8
Secondary Outcome Measure Information:
Title
Subjective assessment of sleep refreshment
Time Frame
Hour +8
Title
Subjective assessment of sleep quality
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
Digit Symbol Substitution Test
Time Frame
Hour +8
Title
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
Time Frame
Hour +8
Title
Stanford Sleepiness Scale
Time Frame
Hour +13
Title
Vital signs
Time Frame
Hour +8
Title
Adverse events
Time Frame
Hour +13
Title
Subjective number of awakenings
Time Frame
Hour +8
Title
Subjective wake after sleep onset
Time Frame
Hour +8
Title
Subjective total sleep time
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 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
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
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pfizer Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451140&StudyName=A%20Study%20of%20Single-Dose%20Gabapentin%20in%20Transient%20Insomnia%20Induced%20by%20a%20Sleep%20Phase%20Advance
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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