Clinical trial NCT04355169: A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postoperative Gastrointestinal Dysfunction
Keywords: Bowel resection
Gastrointestinal recovery
peripherally acting mu-opioid receptor antagonist
Bowel transection
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Time From the End of Surgery to Time to First Toleration of Solid Food and First Bowel Movement (GI2)
timeFrame: Up to 10 days After Surgery
Secondary outcomes:
measure: Time From the End of Surgery to Time When the Discharge Order is Written
timeFrame: Up to 10 days After Surgery
measure: Percentage of Participants Requiring Postoperative Reinsertion of the Nasogastric Tube
timeFrame: Up to 10 days After Surgery
measure: Percentage of Participants With Nausea on Days 1 Through 3
timeFrame: Days 1 to 3 After Surgery
measure: Percentage of Participants With Vomiting on Days 1 Through 3
timeFrame: Days 1 to 3 After Surgery
measure: Percentage of Participants Discharged by Day 10 Who Are Readmitted for Any Reason Within 30 Days After Discharge From the Hospital
timeFrame: From the Discharge Date (Days 1-10) up to 30 Days After Discharge
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Division of Surgery
state: Kentucky
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Mother Frances Hospital - Tyler
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Clinic Research
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Clinic Surgical Oncology
state: Texas
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: