Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Apnea, Obstructive; Hypopnea Syndrome; Excessive Daytime Sleepiness
Intervention: MK0249 (Drug); Comparator: Placebo (unspecified) (Drug); modafinil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
The purpose of this study is to determine the safety and efficacy of MK0249 in treating
refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep
Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP)
therapy.
Clinical Details
Official title: Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate Safety & Efficacy of MK0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome Appropriately Using nCPAP Therapy
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: To determine the effect of MK0249 after 2 weeks of treatment, compared to placebo, on promoting wakefulness.
Secondary outcome: To determine the effect of MK0249 after 2 weeks of treatment, compared to modafinil.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is male or female and is at least 18 years old and less than 65 years old
- Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome
- Patient has been using nCPAP treatment for at least 2 months prior to Visit 1
- Patient is willing to stay at a sleep laboratory for 4 full days and nights for
observation and assessments
- Patient is willing to refrain from napping for the duration of the study
Exclusion Criteria:
- Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4
months;
- Patient is or has participated in a study with an investigational compound or device
within 30 days of signing the informed consent
- Patient has had asthma-related visit to the emergency room or hospitalization within 6
months of Visit 1
- Patient has donated or received blood products within 8 weeks of signing consent or is
planning on doing either for the duration of the study
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Tucson, Arizona 86712, United States; Recruiting
Call for Information, Phoenix, Arizona 85050, United States; Recruiting
Call for Information, Phoenix, Arizona 85006-0000, United States; Recruiting
Call for Information, Standford, California 94305, United States; Recruiting
Call for Information, Santa Monica, California 90404, United States; Recruiting
Call for Information, South Miami, Florida 33143, United States; Recruiting
Call for Information, Saint Petersburg, Florida 33707, United States; Recruiting
Call for Information, Pembroke Pines, Florida 33026, United States; Recruiting
Call for Information, Naples, Florida 34110, United States; Recruiting
Call for Information, Brandon, Florida 33511, United States; Recruiting
Call for Information, Atlanta, Georgia 30342, United States; Recruiting
Call for Information, Iowa City, Iowa 52242, United States; Recruiting
Call for Information, Overland Park, Kansas 66212, United States; Recruiting
Call for Information, Louisville, Kentucky 40217, United States; Recruiting
Call for Information, Chevy Chase, Maryland 20815, United States; Recruiting
Call for Information, New York, New York 10019, United States; Recruiting
Call for Information, Greenville, North Carolina 27835-6028, United States; Recruiting
Call for Information, Durham, North Carolina 27710, United States; Recruiting
Call for Information, Cincinnati, Ohio 45246-0000, United States; Recruiting
Call for Information, Cincinnati, Ohio 45227, United States; Recruiting
Call for Information, Oklahoma City, Oklahoma 73112, United States; Recruiting
Call for Information, Houston, Texas 77030-0000, United States; Recruiting
Additional Information
Starting date: February 2008
Last updated: October 1, 2008
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