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

Phase 2

Terminated

• Conditions: Postoperative Gastrointestinal Dysfunction
• Interventions: Drug: Placebo; Drug: Naldemedine

• Registration Number: NCT04355169
• Lead Sponsor: Shionogi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Study Start: 2020-11-06
• Primary Completion: 2021-01-04
• Study Completion: 2021-01-04
• Status Verified: 2021-12
• Results First Submitted: 2021-12-17
• Results First Submitted QC: 2021-12-17
• Last Update Submitted: 2021-12-17
• Results First Posted: 2022-01-18
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Naldemedine 1.25 mg	Naldemedine	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.
Naldemedine 2.5 mg	Naldemedine	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.
Naldemedine 5 mg	Naldemedine	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.

Primary Outcome Measures

Name	Time	Method
Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)	Up to 10 days After Surgery

Secondary Outcome Measures

Name	Time	Method
Time From the End of Surgery to Time When the Discharge Order is Written	Up to 10 days After Surgery
Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube	Up to 10 days After Surgery
Percentage of Participants With Nausea on Days 1 Through 3	Days 1 to 3 After Surgery
Percentage of Participants With Vomiting on Days 1 Through 3	Days 1 to 3 After Surgery
Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital	From the Discharge Date (Days 1-10) up to 30 Days After Discharge

Trial Locations

Locations (8)

Norton Hospital; 🇺🇸 Louisville, Kentucky, United States

Banner University Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

CHRISTUS Trinity Clinic Research; 🇺🇸 Tyler, Texas, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

CHRISTUS Mother Frances Hospital - Tyler; 🇺🇸 Tyler, Texas, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

CHRISTUS Trinity Clinic Surgical Oncology; 🇺🇸 Tyler, Texas, United States

University of Louisville Division of Surgery; 🇺🇸 Louisville, Kentucky, United States