A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

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NCT00655369

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Study Location
Pfizer Investigational Site
Glendale, Arizona, 85306, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonrestorative Sleep
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening

- Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos

- PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins.

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


- MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening


- BMI = or > 32 kg/m2


- History or presence of breathing related disorders


- PSG findings consistent with and periodic limb movement disorder, narcolepsy or other
dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb
movement with arousal index > 10/hr.

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Nonrestorative SleepA Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
NCT00655369
  1. Glendale, Arizona
  2. Phoenix, Arizona
  3. Tucson, Arizona
  4. Little Rock, Arkansas
  5. Los Angeles, California
  6. Pasadena, California
  7. San Diego, California
  8. San Francisco, California
  9. Tustin, California
  10. Wheat Ridge, Colorado
  11. North Haven, Connecticut
  12. Wallingford, Connecticut
  13. DeLand, Florida
  14. Miami, Florida
  15. Naples, Florida
  16. Orange City, Florida
  17. Orlando, Florida
  18. Pembroke Pines, Florida
  19. South Miami, Florida
  20. Atlanta, Georgia
  21. Atlanta, Georgia
  22. Gainesville, Georgia
  23. Chicago, Illinois
  24. Indianapolis, Indiana
  25. Overland Park, Kansas
  26. Crestview Hills, Kentucky
  27. Lexington, Kentucky
  28. Lexington, Kentucky
  29. Baton Rouge, Louisiana
  30. Chevy Chase, Maryland
  31. Brighton, Massachusetts
  32. N. Dartmouth, Massachusetts
  33. Chesterfield, Missouri
  34. St. Louis, Missouri
  35. Las Vegas, Nevada
  36. Las Vegas, Nevada
  37. West Seneca, New York
  38. Cary, North Carolina
  39. Raleigh, North Carolina
  40. Raleigh, North Carolina
  41. Salisbury, North Carolina
  42. Winston Salem, North Carolina
  43. Winston-Salem, North Carolina
  44. Cincinnati, Ohio
  45. Oklahoma, Oklahoma
  46. Clarks Summit, Pennsylvania
  47. Uniontown, Pennsylvania
  48. Warwick, Rhode Island
  49. West Warwick, Rhode Island
  50. Columbia, South Carolina
  51. Austin, Texas
  52. Dallas, Texas
  53. Irving, Texas
  54. Kelowna, British Columbia
  55. Kelowna, British Columbia
  56. Etobicoke, Ontario
  57. Kitchener, Ontario
  58. Parry Sound, Ontario
  59. Toronto, Ontario
  60. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
Official Title  ICMJE PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep
Brief Summary In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nonrestorative Sleep
Intervention  ICMJE
  • Drug: PD 0200390
    oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: Placebo
    oral placebo daily dose, 3 capsules per dose during a six week treatment period.
Study Arms  ICMJE
  • Experimental: 15 mg
    Intervention: Drug: PD 0200390
  • Experimental: 25 mg
    Intervention: Drug: PD 0200390
  • Experimental: 35 mg
    Intervention: Drug: PD 0200390
  • Experimental: 5 mg
    Intervention: Drug: PD 0200390
  • Experimental: 50 mg
    Intervention: Drug: PD 0200390
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.

*   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: January 20, 2009)		306
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2008)		300
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening
  • Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos
  • PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins.

Exclusion Criteria:

  • MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening
  • BMI = or > 32 kg/m2
  • History or presence of breathing related disorders
  • PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00655369
Other Study ID Numbers  ICMJE A4251033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2012

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