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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-01-31

Brief Summary

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This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.

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Detailed Description

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Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment with prolonged release oxycodone.

Conditions

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Chronic Severe Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Targinact® (oxycodone/naloxone)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* are eligible for Targinact® treatment according to the Targinact® SPC AND
* who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND
* who are constipated (BFI \> 30) AND
* have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No