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

Last updated on May 11, 2018

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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A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
The 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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Transient Insomnia
  • 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
  • Experimental: Gabapentin
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2105
May 2005
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Females who were pregnant or breastfeeding
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00666575
A9451146
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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