The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain (NCT01562483) | Clinical Trial Compass
CompletedPhase 2
The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain
Netherlands36 participantsStarted 2012-10
Plain-language summary
Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain can persist for months or even years and significantly diminishes quality of life. The exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the basis of the present research proposal.
The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.
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:
* Aged 18 years or older
* Pain should have developed after a surgical procedure
* Pain duration exceeding 3 months, and average NRS≥3
* Stable doses intake of analgesics for the past 2 months
* The patient has been informed about the study, understood the information and signed the informed consent form
Exclusion Criteria:
* Diagnosed irritated bowel syndrome (IBS) or chronic pancreatitis
* Patient took cannabinoids on a regular basis for at least one year
* Patient does not feel a pinprick test in the lower extremities
* Patient has a body mass index (BMI) above 36,0 kg/m2
* Patient suffers from serious painful conditions other than chronic pancreatitis
* Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
* Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
* Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
* Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
* Patient has an actual moderate to severe renal impairment
* Patient has an actual moderate to severe hepatic impairment
* Patient has a presence or history of major psychiatric illness
* Patient has experienced an epileptic seizure in the past
* Patient demonstrates clinically significant laboratory abnormalities
* Patient demonstrates a positive urine drug screen fo…
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.