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

Back to Search
Print
Bookmark Trial

NCT00666939

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
San Diego, California, 92108, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Transient InsomniaA Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
NCT00666575
  1. Mobile, Alabama
  2. Phoenix, Arizona
  3. Beverly Hills, California
  4. San Francisco, California
  5. Clearwater, Florida
  6. Deland, Florida
  7. New Port Richey, Florida
  8. Pembroke Pines, Florida
  9. West Palm Beach, Florida
  10. Atlanta, Georgia
  11. Boise, Idaho
  12. Boise, Idaho
  13. Indianapolis, Indiana
  14. Las Vegas, Nevada
  15. Las Vegas, Nevada
  16. Santa Fe, New Mexico
  17. Nashville, Tennessee
  18. Austin, Texas
  19. Fort Worth, Texas
  20. San Antonio, Texas
  21. San Antonio, Texas
  22. Salt Lake City, Utah
  23. West Jordan, Utah
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Transient InsomniaA Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance
NCT00666939
  1. San Diego, California
  2. Ocala, Florida
  3. Atlanta, Georgia
  4. Atlanta, Georgia
  5. Metairie, Louisiana
  6. New York, New York
  7. Thornwood, New York
  8. Raleigh, North Carolina
  9. Duncansville, Pennsylvania
  10. Johnstown, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Transient InsomniaA Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
NCT00659100
  1. Anaheim, California
  2. Bonita, California
  3. Fallbrook, California
  4. Hacienda Heights, California
  5. La Mesa, California
  6. Oceanside, California
  7. Orange, California
  8. San Dimas, California
  9. Pembroke Pines, Florida
  10. Weston, Florida
  11. Baltimore, Maryland
  12. Elk River, Minnesota
  13. Northfield, Minnesota
  14. Red Wing, Minnesota
  15. St. Louis Park, Minnesota
  16. Holly Springs, Mississippi
  17. Belton, Missouri
  18. Independence, Missouri
  19. Albuquerque, New Mexico
  20. Albuquerque, New Mexico
  21. Taos, New Mexico
  22. Cary, North Carolina
  23. Chapel Hill, North Carolina
  24. Raleigh, North Carolina
  25. Raleigh, North Carolina
  26. Raleigh, North Carolina
  27. Houston, Texas
  28. Pearland, Texas
  29. Bountiful, Utah
  30. Ogden, Utah
  31. Salt Lake City, Utah
  32. Syracuse, Utah
  33. West Valley City, Utah
  34. Falls Church, Virginia
  35. Richmond, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Transient InsomniaA Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
NCT00667108
  1. Anaheim, California
  2. San Diego, California
  3. Orlando, Florida
  4. Boise, Idaho
  5. Mt. Laurel, New Jersey
  6. Cincinnati, Ohio
  7. Spartanburg, South Carolina
  8. Dallas, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not 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 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
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Gabapentin
  • Experimental: B
    Intervention: Drug: Gabapentin
  • Placebo Comparator: C
    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
Actual Enrollment  ICMJE
 (submitted: April 23, 2008)		773
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 NCT00666939
Other Study ID Numbers  ICMJE A9451141
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP