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

Severe Pain Clinical Trial

Official title:

The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983137
• Other study ID #: OXN9510
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: November 6, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Mundipharma CVA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium:Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1338
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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®.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Severe Pain

Intervention

Drug:
• Targinact® (oxycodone/naloxone)

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp (UZA):	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma CVA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Up to 140 days	No
Secondary	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.	Up to 140 days	No
Secondary	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).	Up to 140 days	No
Secondary	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.	Up to 140 days	No
Secondary	The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded		Up to 140 days	No
Secondary	Efficacy of Targinact® treatment, with regard to bowel function, 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".	Up to 140 days	No
Secondary	The patient satisfaction will be evaluated by patient in 7 categories	much worse, worse, slightly worse, same, slightly better, better, much better.	Up to 140 days	No
Secondary	The patient's quality of life will be evaluated via the EQ-5D questionnaire		Up to 140 days	No