Primary Objective: - To investigate the analgesic efficacy of a stable dose Namisol® in patients suffering from persistent postsurgical abdominal pain. Secondary Objectives:- To investigate the effect of a stable dose Namisol® on central nervous…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
Synonym
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
Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat
pain. This pain can persist for months or even years and significantly
diminishes quality of life. The exact underlying cause for this pain
persistence is still unclear, which makes its treatment still a challenge. The
promising analgesic effects of Δ9-THC in previous research, plus the less
variability in exposure to THC and its metabolites of Namisol® in comparison
with previous Δ9-THC substances form the basis of the present research
proposal.
Study objective
Primary Objective:
- To investigate the analgesic efficacy of a stable dose Namisol® in patients
suffering from persistent postsurgical abdominal pain.
Secondary Objectives:
- To investigate the effect of a stable dose Namisol® on central nervous system
processing (measured by EEG, QST, DNIC) in patients suffering from persistent
postsurgical abdominal pain.
- To evaluate the effect of a stable dose Namisol® on anxiety and depression
(HADS), general health (SF-36), pain catastrophizing (PCS), global impression
of change (PGIC), pain related anxiety (PASS) in patients suffering from
persistent postsurgical abdominal pain.
- To evaluate the effect of a stable dose Namisol® on safety and tolerability
(adverse events) in patients suffering from persistent postsurgical abdominal
pain.
- To evaluate the effect of a stable dose Namisol® on pharmacokinetics (PK) and
pharmacodynamics (PD) in patients suffering from persistent postsurgical
abdominal pain.
- To evaluate the effect of a stable dose Namisol® on body weight and the
amount of supplementary food intake in patients suffering from persistent
postsurgical 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
•Postsurgical pain
•Standard analgesic treatment (paracetamiol/ NSAIDs) failed
•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
Exclusion criteria
•Regular cannabis use in past 3 years.
•Patient is diagnosed with irritated bowel syndrome (IBS), chronic pancreatitis or post cholecystectomy pain syndrome.
•Patient has an indication for a pain treatment other then medication
•Patient took cannabinoids on a regular basisin past 3 years
•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 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 an active hepatitis B, hepatitis C or HIV infection
•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 | EUCTR2012-000812-27-NL |
| ClinicalTrials.gov | NCTnognietbekend |
| CCMO | NL39962.091.12 |