NCT02109640: TACS

A Randomized Blinded Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function After Colorectal Surgery

Completed Phase 3 Results posted Last updated 8 February 2017

What this trial tests

Phase 3 trial testing Targinact in Postoperative Pain in 50 participants. Completed in 1 August 2015.

Timeline

1 October 2014

Primary endpoint
1 August 2015

1 August 2015

Quick facts

Lead sponsor	University of Edinburgh
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	1 October 2014
Primary completion	1 August 2015
Estimated completion	1 August 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• Targinact — full drug profile →
• Oxycodone (oxycodone) — full drug profile →
• Laparoscopic segmental colectomy

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Postoperative Nausea and Vomiting — all drugs for Postoperative Nausea and Vomiting →

Sponsor

University of Edinburgh

Who can join

18 and older, any sex, with Postoperative Pain or Postoperative Nausea and Vomiting. 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.

• Prevalence of Postoperative Gut Dysfunction
  Time frame: Day 3 post-op
  The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation.

Sponsor's own description

Two key requirements for discharge from hospital after major abdominal surgery are adequate oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed discharge after abdominal surgery due to delayed return of gut function, manifesting as nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are the mainstay of postoperative analgesic regimens after abdominal surgery and are highly effective in achieving adequate pain control. However, opioids cause impaired gut function by reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers such as Alvimopan counteract these effects and can accelerate postoperative gut recovery but are expensive and cause cardiac complications; alternative painkillers such as non-steroidal anti-inflammatories are less effective than opioids and have been linked with increased risk of anastomotic leaks.

Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride) and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product confines the naloxone action to the gut to reduce the unwanted side-effects on gut function. Targinact has been shown in patients with chronic severe pain to provide comparable analgesia to other opioid analgesics whilst reducing the unwanted side-effect of constipation.

The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia after colonic resection with reduced postoperative gastrointestinal dysfunction. The surgical procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a consistently reproducible intervention with a postoperative gut dysfunction rate of up to 40% (prospective data from the Edinburgh Colorectal Unit). The main outcome of the study will be return of normal gut function at the time of planned discharge (Day 3).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized open-label phase II study comparing oxycodone-naloxone with oxycodone in early return of gastrointestinal function after laparoscopic colorectal surgery.
   Creamer F, Balfour A, Nimmo S, Foo I, et al · · 2017 · cited 14× · PMID 27762434 · DOI 10.1002/bjs.10322