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Completed

NCT Number: NCT01983137

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

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.

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Key information

Conditions

Severe Pain Chemically-Induced Disorders Chronic Pain Constipation Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Induced Constipation Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Antwerp (UZA):

Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are to be included in the study, are those who meet all of the following criteria based on the SPC.

  • Male or female patients at least 18 years, or older, with severe pain.
  • 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®.

Treatment and study plan

Targinact® (oxycodone/naloxone)

Drug

Primary outcomes

  1. To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain

    Time frame: 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 outcomes

  1. Pain NAS score (0-10) will be measured at each visit

    Time frame: 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.

  2. Bowel Function Index (BFI) will be recorded at each visit

    Time frame: 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).

  3. The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF

    Time frame: Up to 140 days

    If laxative is used, the physician will document if it's used 1/ continuously, 2/ intermittently or 3/ rarely.

  4. The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded

    Time frame: Up to 140 days

  5. Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)

    Time frame: 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".

  6. The patient satisfaction will be evaluated by patient in 7 categories

    Time frame: Up to 140 days

    much worse, worse, slightly worse, same, slightly better, better, much better.

  7. The patient's quality of life will be evaluated via the EQ-5D questionnaire

    Time frame: Up to 140 days

Sponsors and collaborators

Lead sponsor

Mundipharma CVA

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 13, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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