Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives (NCT01812733) | Clinical Trial Compass
CompletedNot Applicable
Non-interventional Study Comparing Targiniq and Oxycodone/Laxatives
Sweden37 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.