A Non-interventional, Observational Study for Quality of Life (Overall Health Assessment) in Patients With Chronic Severe Pain During Targinact® Treatment

• Conditions: Chronic Severe Pain
• Interventions: Drug: Targinact® (oxycodon/naloxon)

• Registration Number: NCT01710917
• Lead Sponsor: Mundipharma CVA

Brief Summary

This non-interventional, observational study evaluates the efficacy of Targinact with regard to quality of life in daily clinical practice in Belgium compared to the previous analgesic treatment.

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 overall health assessment of the patient, 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-19
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Targinact® (oxycodon/naloxon)	Targinact® (oxycodon/naloxon)	-

Primary Outcome Measures

Name	Time	Method
Assess the efficacy of Targinact® treatment	12 weeks	The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment.; During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.

Secondary Outcome Measures

Name	Time	Method
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.
• To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)	12 weeks	To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)

Trial Locations

Locations (1)

University Hospital Brussels (UZ Brussel), Belgium; 🇧🇪 Brussels, Belgium