A Double-Blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep - Full Text View

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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 ]

Estimated Enrollment:	300
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
15 mg: Experimental	Drug: PD 0200390 oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
25 mg: Experimental	Drug: PD 0200390 oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
35 mg: Experimental	Drug: PD 0200390 oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
5 mg: Experimental	Drug: PD 0200390 oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
50 mg: Experimental	Drug: PD 0200390 oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
Placebo: Placebo Comparator	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 apnes-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

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 61 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4251033
First Received:	April 3, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00655369
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00655369