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

Shionogi

Status and phase: Terminated; Phase 2

Conditions: Postoperative Gastrointestinal Dysfunction

Treatments: Drug: Naldemedine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04355169

1902G1721

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 4 patient groups, including a placebo group

Naldemedine 1.25 mg

Experimental group

Description:

Participants will receive 1.25 milligrams (mg) naldemedine twice daily (BID) beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.

Treatment:

Drug: Naldemedine

Naldemedine 2.5 mg

Experimental group

Description:

Participants will receive 2.5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.

Treatment:

Drug: Naldemedine

Naldemedine 5 mg

Experimental group

Description:

Participants will receive 5 mg naldemedine BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.

Treatment:

Drug: Naldemedine

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo BID beginning on the day of surgery (Day 1) and for up to a maximum of 10 days post-surgery.

Treatment:

Drug: Placebo