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
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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