| January 10, 2008 |
| March 26, 2009 |
| February 2008 |
| March 2009 (final data collection date for primary outcome measure) |
| To determine the effect of MK0249 after 2 weeks of treatment, compared to placebo, on promoting wakefulness. [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00620659 on ClinicalTrials.gov Archive Site |
| To determine the effect of MK0249 after 2 weeks of treatment, compared to modafinil. [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy |
| 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. |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
- Sleep Apnea, Obstructive
- Hypopnea Syndrome
- Excessive Daytime Sleepiness
|
- Drug: Comparator: MK0249
- Drug: Comparator: placebo
- Drug: Comparator: modafinil
|
- Experimental: Arm 1: Treatment period 1: MK0249; Treatment period 2: Pbo; Treatment period 3: modafinil
- Experimental: Arm 2: Treatment period 1: Pbo; Treatment period 2: modafinil; Treatment period 3: MK0249
- Experimental: Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Pbo
- Experimental: Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Pbo
- Experimental: Arm 5: Treatment period 1: Pbo; Treatment period 2: MK0249; Treatment period 3: modafinil
- Experimental: Arm 6: Treatment period 1: modafinil; Treatment period 2: Pbo; Treatment period 3: MK0249
|
| |
| |
| Terminated |
| 200 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 64 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00620659 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2007_602, MK0249-015 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| March 2009 |
