A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Phase 2

Completed

• Conditions: Insomnia
• Interventions: Drug: PD 0200390; Drug: Placebo

• Registration Number: NCT00569972
• Lead Sponsor: Pfizer

Brief Summary

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-10
• Primary Completion: 2009-01
• Study Completion: 2009-01
• 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: 682

Inclusion Criteria

• 3 month history of primary insomnia;
• 18 to 64 years
• For the last 3 months-regularly awake unrefreshed and unrestored
• Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

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Exclusion Criteria

• Any history of an Axis 1 psychiatric diagnosis;
• History or presence of any breathing related sleep disorder;
• History or presence of any medical or neurological condition that could interfere with sleep
• Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 mg PD 0200390	PD 0200390	-
30 mg PD 0200390	PD 0200390	-
45 mg PD 0200390	PD 0200390	-
60 mg PD 0200390	PD 0200390	-
Placebo PD 0200390	Placebo	-

Primary Outcome Measures

Name	Time	Method
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.	Weekly

Secondary Outcome Measures

Name	Time	Method
To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.	Weekly
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.	Weekly
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.	Weekly
To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia.	Weekly
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.	Weekly

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Toronto, Ontario, Canada