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

Chronic Severe Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01710917
• Other study ID #: OXN9512
• Status: Recruiting
• Phase: Phase 4
• First received: October 15, 2012
• Last updated: November 11, 2013
• Start date: September 2012
• Est. completion date: January 2014

Study information

• Verified date: November 2013
• Source: Mundipharma CVA
• Contact: Maggie C Wilson
• Email: Info[@]contact-clinical-trials.com
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Severe Pain

Intervention

Drug:
• Targinact® (oxycodon/naloxon)

Locations

Country	Name	City	State
Belgium	University Hospital Brussels (UZ Brussel), Belgium	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma CVA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of Targinact® treatment	The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment.; During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.	12 weeks	No
Secondary	• To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)	To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	No
Secondary	To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)	To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	No
Secondary	To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)	To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	No
Secondary	To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)	To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)	12 weeks	No
Secondary	To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)	To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)	12 weeks	No
Secondary	To assess safety of Targinact® treatment (by physician)	Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.	12 weeks	No