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Sponsored by: |
Orphan Medical |
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Information provided by: | Orphan Medical |
ClinicalTrials.gov Identifier: | NCT00086281 |
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).
Condition | Intervention | Phase |
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Obstructive Sleep Apnea Syndrome |
Drug: Xyrem Drug: Zolpidem + Xyrem Placebo Drug: Xyrem + modafinil Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Placebo-Controlled Multicenter Trial of the Effects of Orally Administered Xyrem (Sodium Oxybate) and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients |
Enrollment: | 60 |
Study Start Date: | November 2003 |
Study Completion Date: | November 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later
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Drug: Xyrem
Xyrem oral solution, 9 g per night in divided doses. 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
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2: Active Comparator
Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
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Drug: Zolpidem + Xyrem Placebo
Zolpidem 10 mg oral tablets + Xyrem placebo were given at bedtime.
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3: Experimental
Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
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Drug: Xyrem + modafinil
Xyrem oral solution 9 g per night in divided doses. 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later. Modafinil oral tablets was given at 8 am of the morning of Xyrem treatment.
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4: Placebo Comparator
Placebo was given at bedtime and again 2.5 to 4 hours later.
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Drug: Placebo
Placebo oral solution was given at bedtime and 2.5 to 4 hours later.
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This study will be conducted as a randomized, crossover study of the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Clinical Research Group of St. Petersburg | |
St. Petersburg, Florida, United States, 33707 | |
Canada, Ontario | |
London Health Sciences Centre, Victoria Campus | |
London, Ontario, Canada, N6A 4G5 |
Study Director: | Yanping Zheng, MD | Jazz Pharmaceuticals, Inc. |
Responsible Party: | Jazz Pharmaceuticals, Inc. ( Senior Director Clinical Development ) |
Study ID Numbers: | OMC-SXB-23 |
Study First Received: | June 29, 2004 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00086281 |
Health Authority: | United States: Food and Drug Administration |
Sleep-disordered breathing Obstructive sleep apnea syndrome |
Zolpidem Sleep Apnea Syndromes Apnea Sleep Apnea, Obstructive Respiration Disorders Sleep Disorders Dyssomnias |
Modafinil Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory Sodium Oxybate |
Anesthetics, Intravenous Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Central Nervous System Stimulants Protective Agents Neuroprotective Agents |
Pharmacologic Actions Adjuvants, Anesthesia Pathologic Processes Anesthetics, General GABA Agonists Syndrome Therapeutic Uses Hypnotics and Sedatives GABA Agents Central Nervous System Agents |