Chronic Severe Pain
Conditions
Keywords
Chronic pain, Severe pain, Oxycodon, Naloxon, Opioid-induced constipation, Opioid, Quality of life, Laxative, Analgesic rescue medication
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.
Interventions
DRUGTarginact® (oxycodon/naloxon)
Sponsors
Mundipharma CVA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients enrolled in the study are patients who * are eligible for Targinact® treatment according to the Targinact® SPC AND * who have previously been treated with WHO step 1, 2 or 3 analgesics
Exclusion criteria
are based on the Targinact® SPC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) |
| 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 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) |
Countries
Belgium
Contacts
Primary ContactMaggie C Wilson
Backup ContactJill Kiteley
Outcome results
None listed