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Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244465
First Posted: October 26, 2005
Last Update Posted: September 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
October 24, 2005
October 26, 2005
September 7, 2016
May 2006
September 2016   (Final data collection date for primary outcome measure)
Evaluation of risk for development adverse events, withdrawal syndrome and potential for dependence, abuse, overdose and misuse of Xyrem®. Obtaining information about adherence to Xyrem® prescribing information regarding indication and dosage. [ Time Frame: 12 months ]
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Complete list of historical versions of study NCT00244465 on ClinicalTrials.gov Archive Site
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Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
Post Marketing Non-interventional Surveillance Pharmacoepidemiology Study (PMSS) to Evaluate Long-term Safety, Tolerability and Compliance in Administration of Xyrem® (Sodium Oxybate) Oral Solution in Patients Who Receive Treatment With This Medication in Regular Clinical Practice.
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients being treated with Xyrem®.
Narcolepsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
September 2016
September 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who received Xyrem ® on prescription

Exclusion Criteria:

  • No limitations
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Czech Republic,   Germany,   Ireland,   Italy,   Spain,   Switzerland,   United Kingdom
 
 
NCT00244465
C00302
No
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UCB Pharma
UCB Pharma
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Study Director: UCB Cares +1 877 822 9493 (UCB)
UCB Pharma
September 2016
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