A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00551148
First received: October 27, 2007
Last updated: July 17, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Insomnia |
Drug: PD 0200390 Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography [ Time Frame: weekly ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire. [ Time Frame: weekly ] [ Designated as safety issue: No ]
- Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ. [ Time Frame: weekly ] [ Designated as safety issue: No ]
- PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT) [ Time Frame: weekly ] [ Designated as safety issue: No ]
- Latency to persistent sleep (LPS) as determined by Polysomnography [ Time Frame: weekly ] [ Designated as safety issue: No ]
| Enrollment: | 92 |
| Study Start Date: | October 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 15 mg |
Drug: PD 0200390
oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
|
| Experimental: 30 mg |
Drug: PD 0200390
oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
|
| Experimental: 5 mg |
Drug: PD 0200390
oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
|
| Experimental: 60 mg |
Drug: PD 0200390
oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
|
| Placebo Comparator: Placebo |
Other: Placebo
oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
3 month history of Primary Insomnia (DSM-IV criteria)
Self report sleep criteria for at least 3 nights per week in past month;
sWASO (subjective wake after sleep onset) equal or greater than 60 mins
sLSO (subjective latency to sleep onset) equal or greater than 45 minutes
TST less than or equal to 6.5 hrs
Maintain normal daytime-awake, nighttime-sleep schedule
PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights
TST between 3 to 7 hrs on 2 PSG screening nights
Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights
Exclusion Criteria:
Comorbid psychiatric disease or disorders
History or presence of breathing-related disorders
Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening
History or presence of medical or neurological condition interfering with sleep
Current use of know psychotropic effect medications
Excessive caffeine use
Use of alcohol as a sleep aid or more than 2 standard drinks/day
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551148
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Glendale, Arizona, United States, 85306 | |
| Pfizer Investigational Site | |
| Phenoix, Arizona, United States, 85006 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85006 | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33143 | |
| Pfizer Investigational Site | |
| Naples, Florida, United States, 34110 | |
| Pfizer Investigational Site | |
| South Miami, Florida, United States, 33143 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Crestview Hills, Kentucky, United States, 41017 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Cary, North Carolina, United States, 27511 | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45227 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00551148 History of Changes |
| Other Study ID Numbers: | A4251068 |
| Study First Received: | October 27, 2007 |
| Last Updated: | July 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013