Chronic pancreatitis with persistant abdominal pain MedDRA version: 14.1 Level: PT Classification code 10033649 Term: Pancreatitis chronic System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Namisol
Product Code: A04AD10
Pharmaceutical Form: Tablet
INN or Proposed INN: DRONABINOL
CAS Number: 03/08/1972
Other descriptive name: Tetrahydro-6,6,9-tri methyl-3-penthyl-6 H-dibenzo
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Aged 18 years or older •Confirmed chronic pancreatitis •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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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 32,0 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 for THC, cocaine, MDMA, and amphetamines •Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test •Patient has a history of sensitivity / idiosyncrasy to THC •Patient has a known or suspected lactose intolerance •Female patient is pregnant or breastfeeding •Patient intends to conceive a child during the course of the study •Patient participates in another investigational drug study •Patient has a clinical significant exacerbation in illness •Patient is unwilling or unable to comply with the lifestyle guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To investigate the analgesic efficacy of Namisol® after a stable dose, including step-up, treatment of ?9-THC on the experienced pain intensity in chronic pancreatitis patients suffering from persistent abdominal pain.;Secondary Objective: - To investigate the efficacy of Namisol® after a stable dose, including step-up, treatment of ?9-THC on experimental pain mechanisms (measured by EEG, QST, and DNIC) in chronic pancreatitis patients suffering from persistent abdominal pain. - To investigate the efficacy of Namisol® after a stable dose, including step-up, treatment of ?9-THC on quality of life, depression, anxiety and catastrophizing in chronic pancreatitis patients suffering from persistent abdominal pain. - To evaluate the safety and tolerability (adverse events) of Namisol® after a stable dose, including step-up, treatment of ?9-THC in chronic pancreatitis patients suffering from persistent abdominal pain. - To evaluate the pharmacokinetics (PK) and pharmacodynamic (PD) effects (body sway, HF, feeling high) of Namisol® after a stable dose, including step-up, treatment of ?9-THC in chronic pancreatitis patients suffering from persistent abdominal pain.;Primary end point(s): • Pain intensity (diary) o VAS average pain ;Timepoint(s) of evaluation of this end point: Day 0 (baseline) versus day 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pain intensity (diary) o VAS minimal pain o VAS maximal pain • EEG o ERPs to noxious electrical stimuli o ERPs to auditory stimuli (oddball) o FFT spontaneous EEG • QST (visceral screenings protocol) o Pressure pain thresholds o Electric pain thresholds o Electric wind-up response o DNIC • Questionnaires o Izbicki o PGIC o PCS o VASBond & Lader o VASBowdle o SF-36 o HADS • Pharmacodynamics o Body Sway • Functional o Body weight o Supplementary feeding • Safety o Laboratory o ECG o HF / BP o Adverse events • Pharmacokinetics o THC, 11-OH-THC and THC-COOH concentrations ;Timepoint(s) of evaluation of this end point: Repeatedly, from day 0 (baseline) versus day 52 | — |
Countries
Netherlands
Contacts
Public ContactM. de Vries
Radboud University Nijmegen Medical Centre
Outcome results
None listed