NCT00569972CompletedPhase 2
PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 682
- Locations
- 1
- Primary Endpoint
- To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
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
Arms & Interventions
15 mg PD 0200390
Experimental
Intervention: PD 0200390 (Drug)
30 mg PD 0200390
Experimental
Intervention: PD 0200390 (Drug)
45 mg PD 0200390
Experimental
Intervention: PD 0200390 (Drug)
60 mg PD 0200390
Experimental
Intervention: PD 0200390 (Drug)
Placebo PD 0200390
Experimental
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Time Frame: Weekly
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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