Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-29 @ 2:52 AM
Study NCT ID:
NCT01710904
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain
Sponsor:
Mundipharma CVA
Organization:
Study Overview
Official Title:
The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study.
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.
Detailed Description:
Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment with prolonged release oxycodone.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: