Trials / Completed
CompletedNCT00244465
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 750 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.
Conditions
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2005-10-26
- Last updated
- 2016-09-07
Locations
41 sites across 9 countries: Austria, Belgium, Czechia, Germany, Ireland, Italy, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00244465. Inclusion in this directory is not an endorsement.