Status:
COMPLETED
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives
Lead Sponsor:
Mundipharma AB
Conditions:
Pain
Opioid Induced Constipation
Eligibility:
All Genders
18+ years
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 oxycodo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01812733
Start Date
June 1 2013
End Date
June 1 2015
Last Update
August 7 2015
Active Locations (1)
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1
Rehabiliteringsmedicinska kliniken
Örebro, Sweden