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

Mundipharma

Status: Completed

Conditions: Chronic Severe Pain

Treatments: Drug: Targinact® (oxycodone/naloxone)

Study type: Observational

Funder types: Other

Identifiers

NCT01710904

OXN9511

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.