CompletedNot Applicable

A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain

Belgium68 participantsStarted 2012-09

Plain-language summary

This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.

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: patients included are patients who * are eligible for Targinact® treatment according to the Targinact® SPC AND * who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND * who are constipated (BFI \> 30) AND * have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment Exclusion criteria are based on Targinact® SPC.

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.

What they're measuring

Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone.

Timeframe: 12 weeks

Trial details

NCT IDNCT01710904

SponsorMundipharma CVA

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-07

View on ClinicalTrials.gov More Chronic Severe Pain trials