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CompletedNCT01812733Updated Aug 7, 2015

Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives

An observational study in Pain and Opioid Induced Constipation, sponsored by Mundipharma AB. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-07.

Sponsored by Mundipharma AB · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Pain
  • Opioid Induced Constipation
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In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 301 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Mundipharma AB is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Quality of Life

    Two visits performed over 8 weeks

    Time frame: 8 Weeks

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Study locations

1 site
  • Rehabiliteringsmedicinska kliniken
    Örebro, Sweden
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01812733
Lead sponsor
Mundipharma AB
Responsible party
Sponsor
First posted
Mar 18, 2013
Start date
Jun 2013
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Aug 7, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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