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

NCT00666575

Last updated date
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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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

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Transient InsomniaA Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
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  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
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Transient InsomniaA Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance
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  8. Raleigh, North Carolina
  9. Duncansville, Pennsylvania
  10. Johnstown, Pennsylvania
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Transient InsomniaA Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
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  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
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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
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  8. Dallas, Texas
ALL GENDERS
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Advanced Information
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 Summary 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
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 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 Date Not 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 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