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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
History of Changes
  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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

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 June 18, 2013