Not Signed In -
Drug Abuse |
Hallucinogens; Methadone; Narcotics; PCP (Phencyclidine) |
Clinical Trial: Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription
This study is not yet open for patient recruitment.
Verified by UCB Pharma October 2005
|
Purpose
Patients will be followed up for max 18 months. Information on the adverse events and potential misuse or abuse of Xyrem ® will be collected
| Condition | Phase |
|---|---|
| Narcolepsy | Phase IV |
MedlinePlus related topics: Sleep Disorders
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Post-Marketing Non-Interventional Pharmacoepidemiology Study to Evaluate Long-Term Safety, Tolerability and Compliance in Administration of Xyrem ® (Sodium Oxybate) in Regular Clinical Practice
Further study details as provided by UCB Pharma:
Expected Total Enrollment: 1000
Study start: March 2006
Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patient s who received Xyrem ® on prescription
Exclusion Criteria:
- No limitations
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00244465
UCB - Clinical Trial Call Center +1 877 822 9493
Study chairs or principal investigators
Sonja Buyle, MD, Study Director, UCB Pharma
More Information
Study ID Numbers: C00302
Last Updated: December 8, 2005
Record first received: October 24, 2005
ClinicalTrials.gov Identifier: NCT00244465
Health Authority: European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: October 24, 2005
ClinicalTrials.gov Identifier: NCT00244465
Health Authority: European Union: European Medicines Agency
ClinicalTrials.gov processed this record on 2006-01-10
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