Chronic Severe Pain
Conditions
Keywords
Chronic pain, Severe pain, Oxycodone, Naloxone, Opioid-induced constipation, Opioid, Quality of life, Laxative, Analgesic rescue medication
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.
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 included are patients who * are eligible for Targinact® treatment according to the Targinact® SPC AND * who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND * who are constipated (BFI \> 30) AND * have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment
Exclusion criteria
are based on Targinact® SPC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Outcome results
None listed