Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
|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|
|Actual Primary Completion Date :||June 2014|
|Actual 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)
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|