A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia

Back to Search
Print
Bookmark Trial

NCT00748592

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
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.
Insomnia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 3 month history of primary insomnia

- Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

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


- Any history of psychiatric diagnosis


- History or presence of any breathing related sleep disorder


- History or presence of any medical or neurological condition that could interfere with
sleep


- Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more
than 14 consumed per week

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

InsomniaA Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers
NCT00722306
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
InsomniaA Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
NCT00569972
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Scottsdale, Arizona
  5. Tucson, Arizona
  6. Little Rock, Arkansas
  7. Encino, California
  8. Garden Grove, California
  9. Los Alamitos, California
  10. Newport Beach, California
  11. Redlands, California
  12. San Diego, California
  13. San Diego, California
  14. San Diego, California
  15. Sherman Oaks, California
  16. Colorado Springs, Colorado
  17. Brooksville, Florida
  18. Deland, Florida
  19. Hallandale Beach, Florida
  20. Hallandale Beach, Florida
  21. Jacksonville, Florida
  22. Jupiter, Florida
  23. Maitland, Florida
  24. Miami, Florida
  25. Orlando, Florida
  26. Pembroke Pines, Florida
  27. Spring Hill, Florida
  28. Tampa, Florida
  29. Tampa, Florida
  30. Tampa, Florida
  31. Tampa, Florida
  32. Atlanta, Georgia
  33. Atlanta, Georgia
  34. Gainsville, Georgia
  35. Macon, Georgia
  36. Arlington Heights, Illinois
  37. Chicago, Illinois
  38. Chicago, Illinois
  39. Evansville, Indiana
  40. Newburgh, Indiana
  41. Lexington, Kentucky
  42. Mount Sterlingg, Kentucky
  43. Mt. Sterling, Kentucky
  44. Chevy Chase, Maryland
  45. Ann Arbor, Michigan
  46. Kalamazoo, Michigan
  47. St. Clair Shores, Michigan
  48. Albuquerque, New Mexico
  49. New York, New York
  50. Staten Island, New York
  51. Charlotte, North Carolina
  52. Durham, North Carolina
  53. Winston-Salem, North Carolina
  54. Cincinnati, Ohio
  55. Cleveland, Ohio
  56. Columbus, Ohio
  57. Dayton, Ohio
  58. Kettering, Ohio
  59. Toledo, Ohio
  60. Portland, Oregon
  61. East Providence, Rhode Island
  62. Charleston, South Carolina
  63. Memphis, Tennessee
  64. Austin, Texas
  65. Austin, Texas
  66. Dallas, Texas
  67. Houston, Texas
  68. Houston, Texas
  69. San Antonio, Texas
  70. Newport News, Virginia
  71. Seattle, Washington
  72. Calgary, Alberta
  73. Kelowna, British Columbia
  74. Sydney, Nova Scotia
  75. Brampton, Ontario
  76. Etobicoke, Ontario
  77. Kitchener, Ontario
  78. Mississauga, Ontario
  79. Newmarket, Ontario
  80. Parry Sound, Ontario
  81. Toronto, Ontario
  82. Toronto, Ontario
  83. Toronto, Ontario
  84. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
InsomniaA Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
NCT00748592
ALL GENDERS
65 Years+
years
MULTIPLE SITES
InsomniaA Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
NCT00666796
  1. Miami, Florida
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
Official Title  ICMJE PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia
Brief Summary This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: Placebo
    Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
  • Drug: PD 0200390
    Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
  • Drug: PD 0200390
    Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
  • Drug: PD 0200390
    Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PD 0200390, 5 mg
    Intervention: Drug: PD 0200390
  • Experimental: PD 0200390, 15 mg
    Intervention: Drug: PD 0200390
  • Experimental: PD 0200390, 30 mg
    Intervention: Drug: PD 0200390
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 11, 2009)		0
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2008)		32
Estimated Study Completion Date  ICMJE June 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 3 month history of primary insomnia
  • Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

Exclusion Criteria:

  • Any history of psychiatric diagnosis
  • History or presence of any breathing related sleep disorder
  • History or presence of any medical or neurological condition that could interfere with sleep
  • Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00748592
Other Study ID Numbers  ICMJE A4251026
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 February 2009

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