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

NCT00655369 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2012-07-25

No results posted yet for this study

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.

Conditions

  • Nonrestorative Sleep

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655369 on ClinicalTrials.gov