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

November 11, 2013 updated by: Mundipharma CVA

The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Recruiting
        • University Hospital Brussels (UZ Brussel), Belgium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary and Secondary care

Description

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

Exclusion criteria are based on the Targinact® SPC.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Targinact® (oxycodon/naloxon)
Drug: Targinact® (oxycodon/naloxon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the efficacy of Targinact® treatment
Time Frame: 12 weeks

The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment.

During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess safety of Targinact® treatment (by physician)
Time Frame: 12 weeks
Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation.
12 weeks
• To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
Time Frame: 12 weeks
To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician)
12 weeks
To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
Time Frame: 12 weeks
To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician)
12 weeks
To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
Time Frame: 12 weeks
To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician)
12 weeks
To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
Time Frame: 12 weeks
To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician)
12 weeks
To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)
Time Frame: 12 weeks
To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma CVA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OXN9512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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