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

Mundipharma

Status: Unknown

Conditions: Chronic Severe Pain

Treatments: Drug: Targinact® (oxycodon/naloxon)

Study type: Observational

Funder types: Other

Identifiers

NCT01710917

OXN9512

Details and patient eligibility

About

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.

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 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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,800 participants in 1 patient group

Targinact® (oxycodon/naloxon)

Treatment:

Drug: Targinact® (oxycodon/naloxon)