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A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness

Last updated on December 4, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transient Insomnia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to
screening

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Females who were pregnant or breastfeeding

NCT00666575
Pfizer
Completed
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness

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Descriptive Information
Brief Title  ICMJE A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
Brief SummaryThe purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
Detailed DescriptionNot 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 500 mg oral capsule 30 minutes prior to bedtime for 28 days
  • Drug: Placebo
    Matched placebo oral capsule 30 minutes prior to bedtime for 28 days
Study Arms  ICMJE
  • Experimental: Gabapentin
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Not Provided


*   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
Estimated Enrollment  ICMJE
 (submitted: April 23, 2008)
2105
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening

Exclusion Criteria:

  • Females who were pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, 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 NCT00666575
Other Study ID Numbers  ICMJE A9451146
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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