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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Nonrestorative Sleep

Treatments: Drug: PD 0200390; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655369

A4251033

Details and patient eligibility

About

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.

Enrollment: 306 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

306 participants in 6 patient groups, including a placebo group

15 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

25 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

35 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

5 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

50 mg

Experimental group

Treatment:

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Drug: PD 0200390

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo