Δ9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain: a randomized, double-blinded, placebo-controlled, parallel desig

Phase 2

Completed

• Conditions: viscerale pijn; chronic pancreatitis; chronic pancreas inflammation; 10015674

• Registration Number: NL-OMON37765
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

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
• Patient has been informed about the study, understood the information and signed the informed consent form

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 33,0 kg/m2
• 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 takes amitriptyline on a daily basis
• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Pain intensity (diary)<br /><br>o VAS average pain</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Pain intensity (diary)<br /><br>o VAS minimal pain<br /><br>o VAS maximal pain<br /><br>• EEG<br /><br>o ERPs to noxious electrical stimuli<br /><br>o ERPs to auditory stimuli (oddball)<br /><br>o FFT spontaneous EEG<br /><br>• QST (visceral screenings protocol)<br /><br>o Pressure pain thresholds<br /><br>o Electric pain thresholds<br /><br>o Electric wind-up response<br /><br>o DNIC<br /><br>• Questionnaires<br /><br>o Izbicki<br /><br>o PGIC<br /><br>o PCS<br /><br>o VASBond & Lader<br /><br>o VASBowdle<br /><br>o SF-36<br /><br>o HADS<br /><br>o PASS<br /><br>• Pharmacodynamics<br /><br>o Body Sway<br /><br>• Functional<br /><br>o Body weight<br /><br>o Supplementary feeding<br /><br>• Safety<br /><br>o Laboratory<br /><br>o ECG<br /><br>o HF / BP<br /><br>o Adverse events<br /><br>• Pharmacokinetics<br /><br>o THC, 11-OH-THC and THC-COOH concentrations </p><br>