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Trial record 61 of 133 for:    ZOLPIDEM

Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

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ClinicalTrials.gov Identifier: NCT00086281
Recruitment Status : Completed
First Posted : July 1, 2004
Results First Posted : February 24, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by:
Jazz Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 29, 2004
First Posted Date  ICMJE July 1, 2004
Results First Submitted Date  ICMJE November 11, 2011
Results First Posted Date  ICMJE February 24, 2012
Last Update Posted Date February 24, 2012
Study Start Date  ICMJE November 2003
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI). [ Time Frame: One night of PSG during one night of treatment each per arm. ]
The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting >= 10 seconds, accompanied by oxygen desaturation of >3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting >= 10 seconds, with clear decrease (>50%) from baseline in the amplitude of breathing or a decrease <50% in the amplitude of breathing accompanied by oxygen desaturation of >3% or arousal.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00086281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea Syndrome
Intervention  ICMJE
  • Drug: Xyrem (X)
    Xyrem (Sodium Oxybate) Oral Solution
  • Drug: Zolpidem (Z)
    Zolpidem 10 mg oral tablets
    Other Name: Ambien
  • Drug: Modafinil (M)
    Modafinil Oral Tablets
    Other Name: Provigil
  • Drug: Placebo (P)
    Placebo Oral Solution
Study Arms  ICMJE
  • 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
    Intervention: Drug: Xyrem (X)
  • Active Comparator: 2
    Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
    Interventions:
    • Drug: Zolpidem (Z)
    • Drug: Placebo (P)
  • 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).
    Interventions:
    • Drug: Xyrem (X)
    • Drug: Modafinil (M)
  • Placebo Comparator: 4
    Placebo was given at bedtime and again 2.5 to 4 hours later.
    Intervention: Drug: Placebo (P)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2008)
60
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
48
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed and dated an informed consent prior to beginning protocol required procedures.
  • Willing and able to complete the entire trial as per the protocol including 6 nights in the sleep lab.
  • 18 years of age or older.
  • Have a history of obstructive sleep apnea syndrome (as per American Academy of Sleep Medicine [AASM] Task Force 1999).
  • Apnea-Hypopnea Index(AHI): 10 to 40 inclusive, lowest O2 saturation ≥75% (see AASM Task Force 1999 criteria)
  • Females may be included who are surgically sterile, two years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial.
  • In the opinion of the investigator have adequate support for the duration of the trial to include transportation to and from the trial site. In addition, if in the investigator's assessment it is clinically indicated, the patient is willing to not operate a car or heavy machinery for the duration of the trial or for as long as the investigator deems clinically indicated.

Exclusion Criteria:

  • Have taken sodium oxybate (GHB) in the last 30 days.
  • Have taken any investigational therapy within the 30-day period prior to the initial screening visit for this trial.
  • Are routinely taking any stimulant medications, sedative hypnotics, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the start of the study. Patients taking anticonvulsants are not eligible to participate even if they are willing to washout anticonvulsants for the trial.
  • Regularly consume alcohol and are unwilling or unable to totally abstain from alcohol use for the trial duration.
  • Are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol.
  • Have psychiatric disorders, major affective or psychotic disorders, or other problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms.
  • Have a current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by the DSM-IV.
  • Have a serum creatinine greater than 2.0 mg/dL, abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal), or elevated serum bilirubin (more than 1.5 times the upper limit of normal), or pre-trial ECG results demonstrating clinically significant arrhythmias, greater than a first degree AV block or a history of myocardial infarction within the last six months.
  • Have an occupation that requires variable shift work or routine night shift.
  • Have a clinically significant history of seizure disorder either past or present, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past invasive intracranial surgery, and are taking anticonvulsant medications.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00086281
Other Study ID Numbers  ICMJE OMC-SXB-23
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Senior Director Clinical Development, Jazz Pharmaceuticals, Inc.
Study Sponsor  ICMJE Jazz Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yanping Zheng, MD Jazz Pharmaceuticals, Inc.
PRS Account Jazz Pharmaceuticals
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP