NCT01318369 (Delta-pain) is a Phase 2 clinical trial of Namisol in Cannabinoid, sponsored by Radboud University Medical Center.

Who is sponsoring NCT01318369?

NCT01318369 is sponsored by Radboud University Medical Center.

What drugs are being tested in NCT01318369?

Interventions in NCT01318369: Namisol, Diazepam.

What condition does NCT01318369 study?

NCT01318369 studies Cannabinoid, Tetrahydrocannabinol, Chronic Pancreatitis, Abdominal Pain.

Is NCT01318369 still recruiting?

NCT01318369 is currently completed. Last updated 8 July 2013.

Last reviewed 2013-07-08 · How we verify

NCT01318369: Delta-pain

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Safety, Tolerability, and Analgesic Efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

Completed Phase 2 Last updated 8 July 2013

What this trial tests

Phase 2 trial testing Namisol in Cannabinoid in 24 participants. Completed in 1 May 2013.

Timeline

1 October 2011

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	1 October 2011
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across Netherlands

Drugs / interventions tested

Namisol — full drug profile →
Diazepam (diazepam) — full drug profile →

Conditions studied

Cannabinoid — all drugs for Cannabinoid →
Tetrahydrocannabinol — all drugs for Tetrahydrocannabinol →
Chronic Pancreatitis — all drugs for Chronic Pancreatitis →
Abdominal Pain — all drugs for Abdominal Pain →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Cannabinoid or Tetrahydrocannabinol. 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.

Pain intensity (VAS pain)
Time frame: Repeatedly; baseline until 6 hours after administration
Pain intensity (VAS pain at rest and on movement)

Sponsor's own description

The main goal of this trial is to study the efficacy of Namisol® after a single dose of Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are included to provide insight in underlying nociceptive processing.

Publications & conference data

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

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
Single dose delta-9-tetrahydrocannabinol in chronic pancreatitis patients: analgesic efficacy, pharmacokinetics and tolerability.
de Vries M, Van Rijckevorsel DC, Vissers KC, Wilder-Smith OH, et al · · 2016 · cited 33× · PMID 26505163 · DOI 10.1111/bcp.12811
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

Verify or expand the search:

Other Radboud University Medical Center trials

Trials by the same sponsor.

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NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01318369 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
Last refreshed: 8 July 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01318369.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing