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

September 5, 2016 updated by: UCB Pharma

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • 9
      • Innsbruck, Austria
        • 5
  • Belgium
      • Antwerpen, Belgium
        • 12
      • Brugge, Belgium
        • 28
      • Brussels, Belgium
        • 13
      • Gent, Belgium
        • 34
      • Leuven, Belgium
        • 35
      • Liege, Belgium
        • 10
  • Czech Republic
      • Praha 2, Czech Republic
        • 16
  • Germany
      • Berlin, Germany
        • 24
      • Berlin, Germany
        • 25
      • Bremen, Germany
        • 22
      • Hofheim/Taunus, Germany
        • 19
      • Katzenelnbogen, Germany
        • 42
      • Münster, Germany
        • 23
      • Regensburg, Germany
        • 20
      • Schwalmstadt, Germany
        • 1
      • Ulm, Germany
        • 31
      • Westerstede, Germany
        • 21
  • Ireland
      • Dublin 7, Ireland
        • 4
  • Italy
      • Bologna, Italy
        • 18
  • Spain
      • Baracaldo, Spain
        • 40
      • Barcelona, Spain
        • 11
      • Barcelona, Spain
        • 7
      • Castellon, Spain
        • 17
      • Granada, Spain
        • 32
      • Madrid, Spain
        • 15
      • Madrid, Spain
        • 29
      • Palma de Mallorca, Spain
        • 39
      • San Sebastian, Spain
        • 36
      • Sevilla, Spain
        • 14
      • Sevilla, Spain
        • 37
      • Vigo, Spain
        • 38
      • Vitoria, Spain
        • 30
      • Vitoria, Spain
        • 43
  • Switzerland
      • Barmelweid, Switzerland
        • 41
      • Bern, Switzerland
        • 33
      • Zürich, Switzerland
        • 6
  • United Kingdom
      • Cambridge, United Kingdom
        • 2
      • Essex, United Kingdom
        • 26
      • Leicester, United Kingdom
        • 27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being treated with Xyrem®.

Description

Inclusion Criteria:

  • Patients who received Xyrem ® on prescription

Exclusion Criteria:

  • No limitations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 24, 2005

First Submitted That Met QC Criteria

October 24, 2005

First Posted (Estimate)

October 26, 2005

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C00302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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