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A Non-interventional, Observational Study for Quality of Life (Overall Health Assessment) in Patients With Chronic Severe Pain During Targinact® Treatment

NCT ID: NCT01710917

Last Updated: 2013-11-13

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

UNKNOWN

Total Enrollment

1800 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 evaluates the efficacy of Targinact with regard to quality of life 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 during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are overall health assessment of the patient, 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.

Conditions

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Chronic 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

Study Groups

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Targinact® (oxycodon/naloxon)

Targinact® (oxycodon/naloxon)

Intervention Type DRUG

Interventions

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Targinact® (oxycodon/naloxon)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients enrolled in the study are patients who

* are eligible for Targinact® treatment according to the Targinact® SPC AND
* who have previously been treated with WHO step 1, 2 or 3 analgesics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mundipharma CVA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Brussels (UZ Brussel), Belgium

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Maggie C Wilson

Role: CONTACT

Email: [email protected]

Jill Kiteley

Role: CONTACT

Email: [email protected]

References

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Poelaert J, Koopmans-Klein G, Dioh A, Louis F, Gorissen M, Loge D, Van Op den Bosch J, van Megen YJ. Treatment with prolonged-release oxycodone/naloxone improves pain relief and opioid-induced constipation compared with prolonged-release oxycodone in patients with chronic severe pain and laxative-refractory constipation. Clin Ther. 2015 Apr 1;37(4):784-92. doi: 10.1016/j.clinthera.2015.02.010. Epub 2015 Mar 7.

Reference Type DERIVED
PMID: 25757607 (View on PubMed)

Other Identifiers

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OXN9512

Identifier Type: -

Identifier Source: org_study_id