Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow (NCT01567345) | Clinical Trial Compass
CompletedNot Applicable
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow
France54 participantsStarted 2009-01-14
Plain-language summary
The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.
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:
* Age \> or = 18 years old.
* Patient with advanced cancer.
* Patient with severe pain, i.e. a mean daily pain score \> or = 5 on an numeric rating scale.
* Failure of optimal conventional analgesic therapy : either due to intolerable adverse events or to lack of efficacy, i.e. after having tried opioid rotation techniques, different way of administration, use of rapid-acting narcotics to control acute episodes of pain, use of intravenous morphine by PCA pump.
* Possibility of return home
* Dated and signed informed consent form.
Exclusion Criteria:
* Patient's refusal to participate in the study.
* Ongoing pregnancy.
* Ongoing systemic infection.
* Injection site infection.
* Estimated survival less than 90 days.
* Allergy or intolerance to morphine.
* Contraindication to implantation of an intrathecal catheter.
* Patient treated with a powerful CYP1A2 inhibitor, such as fluvoxamine or enoxacin.
* Intrathecal chemotherapy planned.
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.