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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00244465
First received: October 24, 2005
Last updated: April 10, 2014
Last verified: April 2014

October 24, 2005
April 10, 2014
May 2006
December 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 ] [ Designated as safety issue: Yes ]
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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.
 
Enrolling by invitation
1000
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who received Xyrem ® on prescription

Exclusion Criteria:

  • No limitations
Both
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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
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
April 2014

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