Clinical trial NCT01710917: A Non-interventional, Observational Study for Quality of Life (Overall Health Assessment) in Patients With Chronic Severe Pain During Targinact® Treatment
Official title: The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Severe Pain
Keywords: Chronic pain
Severe pain
Oxycodon
Naloxon
Opioid-induced constipation
Opioid
Quality of life
Laxative
Analgesic rescue medication
Lead sponsor: Mundipharma CVA
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary and Secondary care

Brief summary: 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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Assess the efficacy of Targinact® treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: • To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
timeFrame: 12 weeks
measure: To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
timeFrame: 12 weeks
measure: To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
timeFrame: 12 weeks
measure: To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
timeFrame: 12 weeks
measure: To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)
timeFrame: 12 weeks
measure: To assess safety of Targinact® treatment (by physician)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Brussels (UZ Brussel), Belgium
Study officials:
References:
citation: Poelaert J, Koopmans-Klein G, Dioh A, Louis F, Gorissen M, Loge D, Van Op den Bosch J, van Megen YJ. Treatment with prolonged-release oxycodone/naloxone improves pain relief and opioid-induced constipation compared with prolonged-release oxycodone in patients with chronic severe pain and laxative-refractory constipation. Clin Ther. 2015 Apr 1;37(4):784-92. doi: 10.1016/j.clinthera.2015.02.010. Epub 2015 Mar 7.