Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- Average VAS pain [ Time Frame: Baseline versus day 52 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]THC, 11-OH-THC and THC-COOH concentrations
- Functional parameters [ Time Frame: Baseline until day 52 ] [ Designated as safety issue: No ]
- Body weight
- Supplementary feeding
- Quality of life [ Time Frame: Baseline versus day 52 ] [ Designated as safety issue: No ]Quality of life will be evaluated by questionnaires
- Pharmacodynamics [ Time Frame: Baseline versus day 15 and day 52 ] [ Designated as safety issue: No ]Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551511
|Contact: Marjan de Vries, MSc||0031 24 firstname.lastname@example.org|
|Radboud University Nijmegen Medical Centre||Recruiting|
|Nijmegen, Netherlands, 6500 HB|
|Contact: Marjan de Vries, MSc email@example.com|
|Principal Investigator: Harry van Goor, MD PhD|
|Principal Investigator: Oliver Wilder-Smith, MD PhD|
|Sub-Investigator: Marjan de Vries, MSc|
|Principal Investigator:||Harry van Goor, MD PhD||Radboud University Nijmegen Medical Centre, department of surgery|