Primary objective:- To investigate the analgesic efficacy of a stable dose treatment Namisol® in chronic pancreatitis patients suffering from abdominal pain. Analgesic efficacy is measured as mean difference in visual analogue scale (VAS) score (i.e…
ID
Source
Brief title
Condition
- Other condition
- Exocrine pancreas conditions
Synonym
Health condition
viscerale pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Pain intensity (diary)
o VAS average pain
Secondary outcome
• Pain intensity (diary)
o VAS minimal pain
o VAS maximal pain
• EEG
o ERPs to noxious electrical stimuli
o ERPs to auditory stimuli (oddball)
o FFT spontaneous EEG
• QST (visceral screenings protocol)
o Pressure pain thresholds
o Electric pain thresholds
o Electric wind-up response
o DNIC
• Questionnaires
o Izbicki
o PGIC
o PCS
o VASBond & Lader
o VASBowdle
o SF-36
o HADS
o PASS
• Pharmacodynamics
o Body Sway
• Functional
o Body weight
o Supplementary feeding
• Safety
o Laboratory
o ECG
o HF / BP
o Adverse events
• Pharmacokinetics
o THC, 11-OH-THC and THC-COOH concentrations
Background summary
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.
Study objective
Primary objective:
- To investigate the analgesic efficacy of a stable dose treatment Namisol® in
chronic pancreatitis patients suffering from abdominal pain.
Analgesic efficacy is measured as mean difference in visual analogue scale
(VAS) score (i.e. VASpain) at day 50-52 minus baseline (pre-treatment, day 1),
between placebo vs. Namisol®.
Secundary objectives:
- To investigate the efficacy of Namisol® after a stable dose treatment of Δ9-
THC on experimental pain mechanisms (measured by EEG, QST, and DNIC) in chronic
pancreatitis patients suffering from abdominal pain.
- To investigate the efficacy of Namisol® after a stable dose treatment of Δ9-
THC on changes in pain experience (Izbicki), anxiety and depression (HADS),
general health (SF-36), pain catastrophizing (PCS), global impression of change
(PGIC), pain related anxiety (PASS) in chronic pancreatitis patients suffering
from abdominal pain.
- To evaluate the safety and tolerability (adverse events) of Namisol® after a
stable dose treatment of Δ9-THC in chronic pancreatitis patients suffering from
abdominal pain.
- To evaluate the pharmacokinetics (PK) of Namisol® after a stable dose
treatment of Δ9-THC in chronic pancreatitis patients suffering from abdominal
pain.
- To evaluate pharmacodynamic (PD) effects (body sway, HF, feeling high) of
Namisol® after a stable dose treatment of Δ9-THC in chronic pancreatitis
patients suffering from abdominal pain.
Study design
A randomized, double-blind, placebo-controlled, parallel design to evaluate the
analgesic properties of Namisol® during a 50-52 days add-on treatment.
Intervention
Namisol® with standardized Δ9-THC content or identical matching placebos will
be administered orally to evaluate the analgesic properties of Namisol® during
a 52 days add-on treatment to other analgesics. The study 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.
Study burden and risks
The risks of participation include the possible side-effects of the study drug
(i.e. tachycardia, feeling high, disturbance in attention, drowsiness, nausea)
and findings of testing (i.e. positive test result for hepatitis B, hepatitis C
or HIV). The patients participating will obtain no direct personal benefit.
However, patients receiving active study treatment may experience pain relief
during the investigation period. It is the hope that results conducted from the
study will provide new insight to pain mechanisms, and future treatment options
for CP patients. An alternative pain treatment is highly desirable in
particularly this group of patients.
Postbus 9101
9500 HB Nijmegen
NL
Postbus 9101
9500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
• 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
• Patient has been informed about the study, understood the information and signed the informed consent form
Exclusion criteria
• 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 33,0 kg/m2
• 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 takes amitriptyline on a daily basis
• 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000730-19-NL |
| CCMO | NL39537.091.12 |
| Other | nog niet bekend |