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

1338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Severe Pain

Keywords

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Chronic pain Severe pain oxycodon naloxon opioid-induced constipation opioid quality of life laxative analgesic rescue medication

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Antwerp (UZA):

Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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OXN9510

Identifier Type: -

Identifier Source: org_study_id