A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Postoperative Gastrointestinal Dysfunction

In brief

The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.

Key facts

Study ID

NCT04355169

Run by

Shionogi

People needed

2

Starts

2020-11-06

Expected to finish

2021-01-04

Last updated by the study team

2022-01-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo 1 of the following procedures via open (nonlaparoscopic) surgery under general anesthesia:
• partial small or large bowel resection with primary anastomosis
• radical cystectomy requiring bowel transection with primary anastomosis
• Planned to be managed postoperatively with an enhanced recovery protocol, which, at a minimum, includes all of the following elements:
• early removal of the nasogastric tube, which is defined as removal of the nasogastric tube at the end of surgery
• early ambulation, which is defined as ambulation on Day 1
• early diet advancement on Day 1
• Planned to receive primary postoperative pain management with opioid analgesia administered by any route.
• American Society of Anesthesiologists (ASA) Physical Status Score of I, II, or III (a normal healthy participant, a participant with mild systemic disease, and a participant with systemic disease, respectively).

You may not qualify if…

• Scheduled to undergo a total colectomy or any procedure that results in a colostomy or ileostomy.
• Scheduled for endoscopic or laparoscopic surgery.
• Complete bowel obstruction.
• Complicated inflammatory bowel disease (such as ulcerative colitis or Crohn's disease).
• More than 2 major abdominal surgery (for example, gastrectomy, gastric bypass, gastric sleeve, lap banding, pancreatic resection, hepatectomy, intestinal transplant).
• More than 3 doses of an opioid (regardless of the route of administration) during the 7 days prior to surgery.
• Pregnancy or lactation.
• Presence of peritoneal catheter (for example, for dialysis or chemotherapy).

Where it is running

• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Norton Hospital — Louisville, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• University of Louisville Division of Surgery — Louisville, Kentucky, United States
• Houston Methodist Hospital — Houston, Texas, United States
• CHRISTUS Mother Frances Hospital - Tyler — Tyler, Texas, United States
• CHRISTUS Trinity Clinic Research — Tyler, Texas, United States
• CHRISTUS Trinity Clinic Surgical Oncology — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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