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 pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment.
Detailed description
Patients are treated with Targinact® according to daily clinical practice and are monitored during 3 study visits. Parameters assessed are efficacy regarding pain relief, efficacy regarding bowel function, pain relief, use of analgesic rescue medication, bowel function, use of laxatives, safety of Targinact treatment, use of concomitant medication, patient satisfaction and quality of life.
Interventions
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 who are to be included in the study, are those who meet all of the following criteria based on the SPC. 1. Male or female patients at least 18 years, or older, with severe pain. 2. Patients with documented history of severe pain treated with WHO step 1, step 2 and/or 3 analgesics with insufficient pain relief and/or unacceptable side effects that require around-the-clock opioid therapy and are likely to benefit from WHO step 3 opioid therapy for the duration of the study.
Exclusion criteria
are based on the SPC of Targinact®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain | Up to 140 days | Efficacy will be evaluated by the physician (7 categories). For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact®therapy. A non-responder is defined as a patient responding same, slightly worse, worse, much worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain NAS score (0-10) will be measured at each visit | Up to 140 days | The relative changes from baseline at each visit will be used to compare the NAS pain scores during the Targinact® therapy. |
| Bowel Function Index (BFI) will be recorded at each visit | Up to 140 days | The Bowel Function Index is the mean value of the 3 single items included in the BFI:1/ Difficulty of bowel movement (0 to 100; 0 = easy/no difficulty, 100 = severe difficulty); 2/ Feeling of incomplete bowel evacuation (0 to 100; 0 = not at all, 100 = very strong); 3/ Judgement of constipation (0 to 100; 0 = not at all, 100 = very strong). |
| The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF | Up to 140 days | If laxative is used, the physician will document if it's used 1/ continuously, 2/ intermittently or 3/ rarely. |
| The patient's quality of life will be evaluated via the EQ-5D questionnaire | Up to 140 days | — |
| Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories) | Up to 140 days | For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact® therapy. A non-responder is defined as a patient responding same, slightly worse, worse, much worse. |
| The patient satisfaction will be evaluated by patient in 7 categories | Up to 140 days | much worse, worse, slightly worse, same, slightly better, better, much better. |
| The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded | Up to 140 days | — |
Countries
Belgium
Outcome results
None listed