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

Completed

• Conditions: Severe Pain

• Registration Number: NCT01983137
• Lead Sponsor: Mundipharma CVA

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-04-17
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-06
• Last Update Submitted: 2013-11-06
• Study First Posted: 2013-11-13
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1338

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain	Up to 140 days	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".

Secondary Outcome Measures

Name	Time	Method
Bowel Function Index (BFI) will be recorded at each visit	Up to 140 days	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).
The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded	Up to 140 days
Pain NAS score (0-10) will be measured at each visit	Up to 140 days	The relative changes from baseline at each visit will be used to compare the NAS pain scores during the Targinact® therapy.
The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF	Up to 140 days	If laxative is used, the physician will document if it's used 1/ continuously, 2/ intermittently or 3/ rarely.
Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)	Up to 140 days	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".
The patient's quality of life will be evaluated via the EQ-5D questionnaire	Up to 140 days
The patient satisfaction will be evaluated by patient in 7 categories	Up to 140 days	much worse, worse, slightly worse, same, slightly better, better, much better.

Trial Locations

Locations (1)

University Hospital Antwerp (UZA): 🇧🇪 Antwerp, Belgium