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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00569972

Purpose

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

Condition	Intervention	Phase
Insomnia	Drug: PD 0200390 Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
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. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Enrollment:	682
Study Start Date:	October 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
15 mg PD 0200390: Experimental	Drug: PD 0200390 Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
30 mg PD 0200390: Experimental	Drug: PD 0200390 Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
45 mg PD 0200390: Experimental	Drug: PD 0200390 Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
60 mg PD 0200390: Experimental	Drug: PD 0200390 Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Placebo PD 0200390: Experimental	Drug: Placebo Matched oral placebo for weeks 2-7.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569972

Show 84 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4251037
Study First Received:	December 6, 2007
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00569972 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on May 06, 2009