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

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Pain
• Intervention / Treatment: Drug: Targinact® (oxycodone/naloxone)

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 Type: Observational
• Enrollment (Actual): 1338

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • University Hospital Antwerp (UZA):

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

GPs and specialists

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded		Up to 140 days
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
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
The patient's quality of life will be evaluated via the EQ-5D questionnaire		Up to 140 days

Collaborators and Investigators

• Sponsor: Mundipharma CVA

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (ESTIMATE): November 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: opioid; quality of life; Chronic pain; opioid-induced constipation; Severe pain; laxative; oxycodon; naloxon; analgesic rescue medication
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Naloxone; Oxycodone
• Other Study ID Numbers: OXN9510