Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
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|ClinicalTrials.gov Identifier: NCT01551511|
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : October 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Chronic Abdominal Pain Chronic Pain||Drug: Tetrahydrocannabinol Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
|Experimental: delta-9-tetrahydrocannabinol (namisol)||
The add-on treatment consists of two phases: a step-up phase (day 1-5: 3 mg TID; day 6-10: 5 mg TID), and a stable dose phase (day 11-52: 8 mg TID). The dosage may be tapered to at least 5 mg TID, when 8 mg is not tolerated.
|Placebo Comparator: Placebo||
Identical step-up approach to the Namisol arm.
- Average VAS pain [ Time Frame: Baseline versus day 52 ]The primary outcome measure is defined as the reduction in average VAS pain scores at the end of the study (day 50-52) compared to the pre-treatment level between the Namisol® and placebo group, measured by a Visual Analoge Scale (VAS) in a daily pain diary.
- EEG [ Time Frame: Baseline and day 52 ]Electroencephalogram; measuring evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and FFT of spontaneous EEG.
- QST [ Time Frame: Baseline versus day 15 and day 52 ]Quantitative Sensory Testing; measuring pressure pain thresholds, electrical thresholds, electric wind-up response, and DNIC.
- Safety [ Time Frame: Baseline until follow-up (day 59-61) ]
- HF / BP
- Adverse events
- 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 ]THC, 11-OH-THC and THC-COOH concentrations
- Functional parameters [ Time Frame: Baseline until day 52 ]
- Body weight
- Supplementary feeding
- Quality of life [ Time Frame: Baseline versus day 52 ]Quality of life will be evaluated by questionnaires
- Pharmacodynamics [ Time Frame: Baseline versus day 15 and day 52 ]Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551511
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500 HB|
|Principal Investigator:||Harry van Goor, MD PhD||Radboud University Nijmegen Medical Centre, department of surgery|