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

NCT04355169 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 1902G1721
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 8

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.

Conditions

Postoperative Gastrointestinal Dysfunction

Keywords

Bowel resection; Gastrointestinal recovery; peripherally acting mu-opioid receptor antagonist; Bowel transection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (4)

Naldemedine 1.25 mg

EXPERIMENTAL

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.

Drug: Naldemedine

Naldemedine 2.5 mg

EXPERIMENTAL

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.

Drug: Naldemedine

Naldemedine 5 mg

EXPERIMENTAL

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.

Drug: Naldemedine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Naldemedine DRUG

Oral tablet

Also known as: S-297995

Naldemedine 1.25 mg; Naldemedine 2.5 mg; Naldemedine 5 mg

Placebo DRUG

Oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Shionogi: lead

Study Sites (8)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville Division of Surgery

Louisville, Kentucky, 40208, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

CHRISTUS Mother Frances Hospital - Tyler

Tyler, Texas, 75701, United States

Location

CHRISTUS Trinity Clinic Research

Tyler, Texas, 75702, United States

Location

CHRISTUS Trinity Clinic Surgical Oncology

Tyler, Texas, 75702, United States

Location

MeSH Terms

Interventions

naldemedine

Limitations and Caveats

This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator Clinical Support Help Line
• Organization: Shionogi Inc.

shionogiclintrials-admin@shionogi.co.jp

800-849-9707

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: November 6, 2020
• Primary Completion: January 4, 2021
• Study Completion: January 4, 2021
• Last Updated: January 18, 2022
• Results First Posted: January 18, 2022

Record last verified: 2021-12

Locations

US (8)