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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
San Diego, California, 92108 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
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Aged >/= 18 years

- Females of child-bearing potential using medically-acceptable method of birth control
>/= 1 month prior to screening

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

- 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

NCT00666939
Pfizer
Completed
A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance

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A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance
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.
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 100 mg oral capsule 30 minutes prior to bedtime
  • Drug: Gabapentin
    Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
  • Drug: Placebo
    Matched placebo 30 minutes prior to bedtime
  • Experimental: A
    Intervention: Drug: Gabapentin
  • Experimental: B
    Intervention: Drug: Gabapentin
  • Placebo Comparator: C
    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
773
January 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00666939
A9451141
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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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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