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Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

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Condition or disease Intervention/treatment Phase
Pancreatitis, Chronic Abdominal Pain Chronic Pain Drug: Tetrahydrocannabinol Drug: Placebo Phase 2

Layout table for study information

Study Type : Interventional (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design
Study Start Date : October 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014
  • Laboratory
  • ECG
  • HF / BP
  • Adverse events
  • Body weight
  • Supplementary feeding

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
  • 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
  • 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

Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain The safety and scientific validity of this study is the responsibility of the study sponsor and