Clinical trial NCT00748592: A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
Official title: PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Insomnia
Keywords: Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.


Eligibility criteria: Inclusion Criteria:

* 3 month history of primary insomnia
* 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 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

Primary outcomes:
measure: Wake After Sleep Onset (WASO) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Secondary outcomes:
measure: Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
measure: Latency to persistent sleep (LPS) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Latency to REM Sleep as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Sleep efficiency (SE) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Number of awakenings after sleep onset (NAASO) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Total wake time (TWT) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness
timeFrame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
measure: Number of arousals as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Total sleep time (TST) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Next day performance sa determined by Digit Symbol Substitution Test (DSST)
timeFrame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
measure: Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)
timeFrame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
measure: Wake time during sleep (WTDS) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Wake time after sleep (WTAS) as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment
timeFrame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
measure: Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)
timeFrame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: