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

Mundipharma

Status: Completed

Conditions: Severe Pain

Treatments: Drug: Targinact® (oxycodone/naloxone)

Study type: Observational

Funder types: Other

Identifiers

NCT01983137

OXN9510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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®.