NCT01551511

Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design

Completed Phase 2 Last updated 27 October 2014

What this trial tests

Phase 2 trial testing Tetrahydrocannabinol in Pancreatitis, Chronic in 29 participants. Completed in 1 June 2014.

Timeline

1 October 2012

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	29
Start date	1 October 2012
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	1 location across Netherlands

Drugs / interventions tested

• Tetrahydrocannabinol — full drug profile →
• Placebo

Conditions studied

• Pancreatitis, Chronic — all drugs for Pancreatitis, Chronic →
• Abdominal Pain — all drugs for Abdominal Pain →
• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Pancreatitis, Chronic or Abdominal Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Opioid-sparing effect of cannabinoids for analgesia: an updated systematic review and meta-analysis of preclinical and clinical studies.
   Nielsen S, Picco L, Murnion B, Winters B, et al · · 2022 · cited 61× · PMID 35459926 · DOI 10.1038/s41386-022-01322-4
2. Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study.
   de Vries M, van Rijckevorsel DCM, Vissers KCP, Wilder-Smith OHG, et al · · 2017 · cited 54× · PMID 27720917 · DOI 10.1016/j.cgh.2016.09.147
3. Modulation of Human Peripheral Blood Mononuclear Cell Signaling by Medicinal Cannabinoids.
   Utomo WK, de Vries M, Braat H, Bruno MJ, et al · · 2017 · cited 14× · PMID 28174520 · DOI 10.3389/fnmol.2017.00014
4. Applications of Cannabinoids in Neuropathic Pain: An Updated Review.
   Arthur P, Kalvala AK, Surapaneni SK, Singh MS. · · 2024 · cited 12× · PMID 37824417 · DOI 10.1615/critrevtherdrugcarriersyst.2022038592
5. UEG Week 2014 Oral Presentations
   · 2014 · cited 1×