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A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment

Primary Purpose

Transient Insomnia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
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:

  • Age of 18 years or older with symptoms of sleeplessness
  • Provided informed consent

Exclusion Criteria:

  • Contraindications to use of gabapentin

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

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)

Secondary Outcome Measures

Adverse events

Full Information

First Posted
April 1, 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
NCT00659100
Brief Title
A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
Official Title
A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (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 consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 50 mg oral capsule 30 minutes before bedtime
Primary Outcome Measure Information:
Title
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
Time Frame
Throughout Day 90
Title
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
Time Frame
Throughout Day 90
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18 years or older with symptoms of sleeplessness Provided informed consent Exclusion Criteria: Contraindications to use of gabapentin
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
Bonita
State/Province
California
ZIP/Postal Code
91902
Country
United States
Facility Name
Pfizer Investigational Site
City
Fallbrook
State/Province
California
ZIP/Postal Code
92028
Country
United States
Facility Name
Pfizer Investigational Site
City
Hacienda Heights
State/Province
California
ZIP/Postal Code
91746
Country
United States
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pfizer Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92866
Country
United States
Facility Name
Pfizer Investigational Site
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Pfizer Investigational Site
City
Weston
State/Province
Florida
ZIP/Postal Code
33326
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Pfizer Investigational Site
City
Elk River
State/Province
Minnesota
ZIP/Postal Code
55330
Country
United States
Facility Name
Pfizer Investigational Site
City
Northfield
State/Province
Minnesota
ZIP/Postal Code
55057
Country
United States
Facility Name
Pfizer Investigational Site
City
Red Wing
State/Province
Minnesota
ZIP/Postal Code
55066
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Pfizer Investigational Site
City
Holly Springs
State/Province
Mississippi
ZIP/Postal Code
38625
Country
United States
Facility Name
Pfizer Investigational Site
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
Pfizer Investigational Site
City
Independence
State/Province
Missouri
ZIP/Postal Code
64054
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87104
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
Pfizer Investigational Site
City
Taos
State/Province
New Mexico
ZIP/Postal Code
87571
Country
United States
Facility Name
Pfizer Investigational Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Facility Name
Pfizer Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27606
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77088
Country
United States
Facility Name
Pfizer Investigational Site
City
Pearland
State/Province
Texas
ZIP/Postal Code
77581
Country
United States
Facility Name
Pfizer Investigational Site
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Pfizer Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84401
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Pfizer Investigational Site
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
Pfizer Investigational Site
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Pfizer Investigational Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451159&StudyName=A%20Trial%20to%20Assess%20Consumer%20Self-Selection%20and%20Use%20of%20Gabapentin%20for%20Occasional%20Sleeplessness%20in%20an%20Over-the-Counter%20Environment
Description
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A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment

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