Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01812733

Enrollment

Registered

2013-03-18

Start date

2013-06-30

Completion date

2015-06-30

Last updated

2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Induced Constipation, Pain

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	8 Weeks	Two visits performed over 8 weeks

Countries

Sweden

Outcome results