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

N/ACompletedNCT01983137

Mundipharma CVA1,338 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,338

Conditions

Severe Pain

Interventions

Targinact® (oxycodone/naloxone)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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®.

Locations (1)

University Hospital Antwerp (UZA):

Antwerp, Belgium

Outcomes

Primary Outcomes

To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain

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".

Time frame: Up to 140 days

Secondary Outcomes

Pain NAS score (0-10) will be measured at each visit

The relative changes from baseline at each visit will be used to compare the NAS pain scores during the Targinact® therapy.

Time frame: Up to 140 days

Bowel Function Index (BFI) will be recorded at each visit

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).

Time frame: Up to 140 days

The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF

If laxative is used, the physician will document if it's used 1/ continuously, 2/ intermittently or 3/ rarely.

Time frame: Up to 140 days

The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded

Time frame: Up to 140 days

Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)

Data from ClinicalTrials.gov

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