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| Sponsor: | Orphan Medical |
|---|---|
| Information provided by: | Orphan Medical |
| ClinicalTrials.gov Identifier: | NCT00086281 |
Purpose
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 |
|---|---|---|
|
Obstructive Sleep Apnea Syndrome |
Drug: Xyrem Drug: Zolpidem + Xyrem Placebo Drug: Xyrem + modafinil Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
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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Active Comparator: 2
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.
Other Name: Ambien
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Experimental: 3
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.
Other Name: Provigil
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Placebo Comparator: 4
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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. |
More Information
| Responsible Party: | Senior Director Clinical Development, Jazz Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00086281 History of Changes |
| Other Study ID Numbers: | OMC-SXB-23 |
| Study First Received: | June 29, 2004 |
| Last Updated: | May 22, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Sleep-disordered breathing Obstructive sleep apnea syndrome |
|
Apnea Respiratory Aspiration Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Sodium Oxybate Modafinil Zolpidem |
Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Stimulants Neuroprotective Agents Protective Agents Hypnotics and Sedatives GABA-A Receptor Agonists GABA Agonists |