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

Phase 2

Completed

• Conditions: Nonrestorative Sleep
• Interventions: Drug: PD 0200390; Drug: Placebo

• Registration Number: NCT00655369
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Disposition First Submitted: 2009-12-10
• Disposition First Submitted QC: 2009-12-10
• Disposition First Posted: 2009-12-14
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 mg	PD 0200390	-
35 mg	PD 0200390	-
5 mg	PD 0200390	-
50 mg	PD 0200390	-
Placebo	Placebo	-
25 mg	PD 0200390	-

Primary Outcome Measures

Name	Time	Method
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)	Weekly

Secondary Outcome Measures

Name	Time	Method
Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire	Weeky
Total score of the Daily Restorative Sleep Questionnaire	Daily
Total score of the Multidimensional Assessment of Fatigue (MAF)	Weekly
Total score of the Sheehan Disability Scale to measure functional impairment	Weekly
Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)	Weekly
Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF)	Weekly
Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity.	Weekly
Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician.	Weekly
Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC).	Weekly

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Toronto, Ontario, Canada