Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Depen... | Not Recruiting
Observational Study to Evaluate Ris... | Not Recruiting
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription

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Medical Conditions
  • Narcolepsy
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT00244465

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 4
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
Primary Outcome Measures
    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.; 12 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
750
Participant Inclusion Criteria
    Inclusion Criteria:

    - Patients who received Xyrem ® on prescription

    Exclusion Criteria:

    - No limitations
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Uni Hospital Leicester
Leicester
Research Site
Essex
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Belgium, Czech Republic, Germany, Ireland, Italy, Spain, Switzerland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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.
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
C00302
Sponsor(s)
UCB Pharma
Key Dates

Recruitment Start Date

May 2006

Recruitment End Date

Aug 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

24 Oct 2005

Date updated in source

17 May 2016