Efficacy study of ?9-THC to treat persistent abdominal pain as a result of chronic pancreas inflammatio
- Conditions
- patients with abdominal pain as a result of chronic pancreatitisMedDRA version: 13.1Level: PTClassification code 10033649Term: Pancreatitis chronicSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 13.1Level: LLTClassification code 10009093Term: Chronic pancreatitisSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-000647-24-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
1.Patient is 18 years or older on the day the informed consent form will be signed.
2.Patient is male.
3.Patient has chronic pancreatitis, diagnosed using the Marseille and Cambridge Classification System (addendum II).37
4.Patient suffers from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain (intermittent or persistent pain on a daily basis in at least 3 months), and must consider their pain as severe enough for medical treatment (average NRS = 3).
5.Patient in de opioid subgroup takes stable doses of opioids, e.g. morphine or tramadol, for the past 2 months on the day of screening. Stable dose intake is defined as a daily equivalent sum of opioid intake according medical prescription within a small deviation range as judged by the investigator.
6.Patient in the non-opioid group does not take any opioids for the past 2 months on the day of screening.
7.Patient is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
8.Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
Are the trial subjects under 18? no
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Patient did not took any cannabinoid (by smoking cannabis or oral intake) for at least one year on the day of screening.
2.Patient is insulin depended for more than 5 years on the day of screening.
3.Patient does not feel a pinprick test in the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
4.Patient has a body mass index (BMI) below 18 or above 31.2 kg/m2.
BMI (kg/m²) = weight (kg) / (height * height) (m2)
5.Patient suffers from serious painful conditions other than chronic pancreatitis or had any major pre-existing chronic pain syndrome.
6.Patient has a (history of) a significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
7.Patient uses any kind of concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient (e.g. HIV antivirals or proton-pump inhibitors).
8.Patient takes drip-feed.
9.Patient takes amitriptyline on a daily base and is unable/unwilling to refrain from amitriptyline from 24 hours before each study day.
10.Patient demonstrates deviating ECG parameters at screening, e.g. heart rate >100 bpm, QRS duration >120 msec, QTc interval >450 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
11.Patient is previously diagnosed with moderate to severe renal impairment, e.g. creatinine values > 2x ULN and/or a significant change of their normal values.
12.Patient is previously diagnosed with moderate to severe hepatic failure or show significant clinical abnormalities in biochemistry blood sample.
13.Patient has a presence or history of major psychiatric illness as judged by investigator, e.g. major depression, schizophrenia.
14.Patient demonstrates clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
15.Patient has a history of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds, or to any other related drug used in the past.
16.Patient shows a positive alcohol breath test at screening or admission and/or is unable/unwilling to refrain from alcohol use from 48 hours before each study day until the last blood sample has been drawn.
17.Patient demonstrates a positive urine screen at screening visit for THC, cocaine, MDMA, and amphetamines.
18.Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test.
19.Patient is unwilling or unable to comply with the lifestyle guidelines.
20.Patients intends to father a child during the course of the study.
21.Patient participates in another investigational drug study within 90 days prior to the first dose and/or participates in more than 2 clinical trials in the last year.
22.Patient has a clinical significant exacerbation in illness within two weeks of participating in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of Namisol® after a single dose of THC on the experienced pain intensity (measured by the VASpain) in patients with chronic pancreatitis.;Secondary Objective: - To investigate the efficacy of Namisol® after a single dose of THC on experimental pain mechanisms (measured by EEG, QST, and DNIC) in patients with chronic pancreatitis.<br>- To evaluate the safety and tolerability of Namisol® after a single dose of THC in patients with chronic pancreatitis.<br>- To evaluate the pharmacokinetics (PK) of Namisol® after a single dose of THC in patients with chronic pancreatitis.<br>- To evaluate (undesirable) pharmacodynamic (PD) effects of Namisol® after a single dose of THC in patients with chronic pancreatitis.<br>;Primary end point(s): Pain intensity:<br>- VAS pain rest<br>- VAS pain movement<br><br>;Timepoint(s) of evaluation of this end point: Repeatedly; baseline until 6 hours after single dose administration
- Secondary Outcome Measures
Name Time Method Secondary end point(s): EEG; ERPs to noxious stimuli and spontaneous EEG <br>QST; mechanical and electrical pain thresholds<br>Body Sway; static 2 dimensional body sway;Timepoint(s) of evaluation of this end point: Repeatedly; baseline until 6 hours after administration