NCT01562483

The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain; a Randomized, Double Blinded, Placebo-controlled, Experiment

Completed Phase 2 Last updated 27 October 2014

What this trial tests

Phase 2 trial testing Tetrahydrocannabinol in Postsurgical Pain in 36 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	36
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

• Postsurgical Pain — all drugs for Postsurgical Pain →
• 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 Postsurgical Pain 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 pain diary.

Sponsor's own description

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 improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the basis of the present research proposal.

The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.

Publications & conference data

4 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