NCT01790555: NamiSur

The Analgesic Efficacy of Perioperative Δ9-THC (Namisol®) in Patients Undergoing Major Abdominal Surgery: A Randomized, Double Blinded, Placebo-controlled, Parallel Design

Status unknown Phase 2 Last updated 22 October 2013

What this trial tests

Phase 2 trial testing Namisol in Pain in 40 participants. Status unknown.

Timeline

1 July 2013

Primary endpoint
1 October 2013

1 April 2014

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	1 July 2013
Primary completion	1 October 2013
Estimated completion	1 April 2014
Sites	1 location across Netherlands

Drugs / interventions tested

• Namisol — full drug profile →
• Diazepam/placebo — full drug profile →

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with 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.

• Analgesic efficacy
  Time frame: Daily until +5 days after surgery
  To investigate the analgesic efficacy of perioperative Namisol® for postsurgical pain at the day of surgery and in the first 5 days after abdominal surgery. Analgesic efficacy is measured as the difference in visual analog scale (VAS) area under the curve (AUC) for the day of surgery and the first 5 postoperative days between placebo and Namisol®.

Sponsor's own description

Adequate treatment of postsurgical pain leads to better mobilization, shorter hospital stay, lower costs and higher patient satisfaction. In its treatment, frequent use is made of opioids. However, opioids have many side-effects. A possible add-on can be sought in THC, which has been shown to have possible analgesic and/or pain modulating effects in preclinical research. The purpose of this study is to investigate the analgesic and pain modulating effects of perioperative Namisol, a tablet containing THC, in patients that will undergo major abdominal surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.