?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01551511
• Date of registration: 07/02/2012
• Prospective Registration: Yes
• Primary sponsor: Radboud University
• Public title: ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
• Scientific title: ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design
• Date of first enrolment: October 2012
• Target sample size: 29
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01551511
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Harry van Goor, MD PhD
• Affiliation: Radboud University Nijmegen Medical Centre, department of surgery

Key inclusion & exclusion 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatitis, Chronic

Abdominal Pain

Chronic Pain

Intervention(s)

Drug: Tetrahydrocannabinol

Drug: Placebo

Primary Outcome(s)

Average VAS pain [Time Frame: Baseline versus day 52]

Secondary Outcome(s)

Pharmacodynamics [Time Frame: Baseline versus day 15 and day 52]

Quality of life [Time Frame: Baseline versus day 52]

EEG [Time Frame: Baseline and day 52]

Safety [Time Frame: Baseline until follow-up (day 59-61)]

Functional parameters [Time Frame: Baseline until day 52]

Pharmacokinetics [Time Frame: Predose levels at baseline, day 15 and day 52; postdose levels (30 min, 45 min, 60 min, 100 min) at day 15 and 52]

QST [Time Frame: Baseline versus day 15 and day 52]

Secondary ID(s)

HEEL-2011-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Union