The analgesic efficacy of Δ9-THC (Namisol®) in patients with persistent postsurgical abdominal pain: a randomized, double-blinded, placebo-controlled, parallel desig

Phase 2

Completed

• Conditions: Abdominal postsurgical pain; adhesion pain; 10069888

• Registration Number: NL-OMON37384
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> • Pain intensity (diary)<br /><br>o VAS average pain </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> • Pain intensity (diary)<br /><br>o VAS minimal pain<br /><br>o VAS maximal pain<br /><br>• EEG<br /><br>o ERPs to noxious electrical stimuli<br /><br>o ERPs to auditory stimuli (oddball)<br /><br>o FFT spontaneous EEG<br /><br>• QST (visceral screenings protocol)<br /><br>o Pressure pain thresholds<br /><br>o Electric pain thresholds<br /><br>o Electric wind-up response<br /><br>o DNIC<br /><br>• Questionnaires<br /><br>o Izbicki<br /><br>o PGIC<br /><br>o PCS<br /><br>o VASBond & Lader<br /><br>o VASBowdle<br /><br>o SF-36<br /><br>o HADS<br /><br>o PASS<br /><br>• Pharmacodynamics<br /><br>o Body Sway<br /><br>• Functional<br /><br>o Body weight<br /><br>o Supplementary feeding<br /><br>• Safety<br /><br>o Laboratory<br /><br>o ECG<br /><br>o HF / BP<br /><br>o Adverse events<br /><br>• Pharmacokinetics<br /><br>o THC, 11-OH-THC and THC-COOH concentrations </p><br>