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

Postoperative Gastrointestinal Dysfunction Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine in Patients Undergoing Surgeries That Include a Bowel Resection or Bowel Transection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04355169
• Other study ID #: 1902G1721
• Status: Terminated
• Phase: Phase 2
• Start date: November 6, 2020
• Est. completion date: January 4, 2021

Study information

• Verified date: December 2021
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 4, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Postoperative Gastrointestinal Dysfunction

Intervention

Drug:
• Naldemedine
Oral tablet
• Placebo
Oral tablet

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas
United States	Norton Hospital	Louisville	Kentucky
United States	University of Louisville Division of Surgery	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Banner University Medical Center - Tucson	Tucson	Arizona
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

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time From the End of Surgery to Time When the Discharge Order is Written		Up to 10 days After Surgery
Secondary	Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube		Up to 10 days After Surgery
Secondary	Percentage of Participants With Nausea on Days 1 Through 3		Days 1 to 3 After Surgery
Secondary	Percentage of Participants With Vomiting on Days 1 Through 3		Days 1 to 3 After Surgery
Secondary	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