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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00655369
First received: April 3, 2008
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Nonrestorative Sleep
Drug: PD 0200390
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly) [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire [ Time Frame: Weeky ] [ Designated as safety issue: No ]
  • Total score of the Daily Restorative Sleep Questionnaire [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Total score of the Multidimensional Assessment of Fatigue (MAF) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Total score of the Sheehan Disability Scale to measure functional impairment [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC). [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mg Drug: PD 0200390
oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 25 mg Drug: PD 0200390
oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 35 mg Drug: PD 0200390
oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 5 mg Drug: PD 0200390
oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 50 mg Drug: PD 0200390
oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
Placebo Comparator: Placebo Drug: Placebo
oral placebo daily dose, 3 capsules per dose during a six week treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655369

  Show 60 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00655369     History of Changes
Other Study ID Numbers: A4251033
Study First Received: April 3, 2008
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014