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NCT01812733 Clinical Trial

Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01812733
Other study ID # OXN9513
Secondary ID
Status Completed
Phase N/A
First received March 14, 2013
Last updated August 6, 2015
Start date June 2013
Est. completion date June 2015

Study information
Verified date August 2015
Source Mundipharma AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Rehabiliteringsmedicinska kliniken Örebro

Sponsors (1)
Lead Sponsor Collaborator
Mundipharma AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life Two visits performed over 8 weeks 8 Weeks No
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