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A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

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NCT00674752

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33143 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 who reported occasional sleeplessness in the month prior to
screening

- 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)

- Currently taking or expected to take any of the following during the trial:
amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates,
propoxyphene, barbituates, and phencyclidine

NCT00674752
Pfizer
Completed
A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

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[email protected]

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A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in 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 250 mg oral capsule 30 minutes prior to bedtime
  • Drug: Gabapentin
    Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
  • Drug: Placebo
    Matched placebo oral capsule 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
377
August 2006
Not Provided

Inclusion Criteria:

  • Aged >/= 18 years who reported occasional sleeplessness in the month prior to screening
  • 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)
  • Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
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
 
 
NCT00674752
A9451157
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 2011

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

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Contact

[email protected]



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