A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain

Completed

• Conditions: Chronic Severe Pain

• Registration Number: NCT01710904
• Lead Sponsor: Mundipharma CVA

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-19
• Primary Completion: 2013-07
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.	12 weeks	A responder is defined as a patient who shows no worsening of pain (pain score has increased ≤ 1 unit on a 11-points pain NRS) at V3/the last visit compared to V1 or has a NRS ≤4 on a 11-points pain NRS at V3/the last visit AND has a reduction in BFI ≥ 12 units at V3/the last visit compared to V1 or has a BFI ≤30 at V3/ the last visit.

Secondary Outcome Measures

Name	Time	Method
To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)	12 weeks	To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)	12 weeks	To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician)
To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)	12 weeks	To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient)
To assess safety of Targinact® treatment (by physician)	12 weeks	Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.

Trial Locations

Locations (1)

University Hospital Brussels; 🇧🇪 Brussels, Belgium