Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01983137
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Severe Pain 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1338 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
GPs and specialists
Criteria

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®.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983137


Locations
Layout table for location information
Belgium
University Hospital Antwerp (UZA):
Antwerp, Belgium
Sponsors and Collaborators
Mundipharma CVA

Layout table for additonal information
Responsible Party: Mundipharma CVA
ClinicalTrials.gov Identifier: NCT01983137     History of Changes
Other Study ID Numbers: OXN9510
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Mundipharma CVA:
Chronic pain
Severe pain
oxycodon
naloxon
opioid-induced constipation
opioid
quality of life
laxative
analgesic rescue medication

Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics
Oxycodone
Naloxone
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Narcotic Antagonists