Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

August 6, 2015 updated by: Mundipharma AB

An Observational Study of Quality of Life, Resource Use and Costs Associated With Treatment of Severe Pain - a Comparison of a Combination of Oxycodone and Naloxone (Targiniq) Versus Oxycodone and Laxatives

The objective of the non-interventional study is to compare the quality of life, health care resource use and costs between the use of a combination of oxycodone and naloxone (Targiniq) versus oxycodone and laxatives for patients with severe pain, and to evaluate the cost-effectiveness of treatment with Targiniq.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

37

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

  • Sweden
      • Örebro, Sweden
        • Rehabiliteringsmedicinska kliniken

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

Non-Probability Sample

Study Population

The patients have severe pain treated with opioids and will be enrolled at different clinics in Sweden

Description

Inclusion criteria:

  • Male or non-pregnant female ≥18 years of age
  • Malignant or non-malignant opioid sensitive pain
  • Must sign an informed consent form (ICF)
  • Must have a stable daily dose of oxycodone prolonged release formulation titrated to analgesic effect (as to be assessed by clinical experts)
  • Use of laxatives for concomitant opioid-induced constipation in an adequate dose and length of time and without sufficient effect
  • BFI ≥30 and state a discomfort caused by the constipation at screening
  • Ability to answer the patient questionnaires and have an estimated overall life expectancy of at least six (6) months

Exclusion criteria:

  • History of, or on-going, abuse of alcohol and/or drugs
  • Inability to read and understand written instructions, ICF or questionnaires
  • Constipation not related to opioid use
  • Unsuitable patient for other reason(s) in the opinion of the investigator
  • Inpatients, if admission and/or discharge is expected during study period

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 8 Weeks
Two visits performed over 8 weeks
8 Weeks

Collaborators and Investigators

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

Sponsor

Mundipharma AB

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

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXN9513

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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