A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery

NCT ID: NCT03827655

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2022-05-27

Brief Summary

The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery.

Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.

Detailed Description

The drug being tested in this study is called TAK-954. In this study TAK-954 is being administered presurgery to evaluate if it can enhance the recovery of GI function postsurgery in participants undergoing open or laparoscopic-assisted partial small- or large-bowel resection. In addition, some participants will also receive TAK-954 postoperatively to evaluate if there is an additional benefit when this drug is administered both pre and post-surgery.

The study will enroll approximately 180 participants. Participants will be equally randomized into one of the three remaining parallel treatment arms- which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

All participants will be given intravenous infusion preoperation and daily postoperation until return of upper and lower GI function or for up to 10 days.

This multi-center trial will be conducted in the United States and Germany. The overall time to participate in this study is up to 100 days. Participants will be treated with the study drug for up to 10 days after surgery or until return of GI function post-surgery (whichever occurs first).

Conditions

Postoperative Gastrointestinal Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.

Group Type: PLACEBO_COMPARATOR

TAK-954 Placebo

Intervention Type: DRUG

TAK-954 placebo-matching intravenous infusion.

TAK-954 0.1 mg/100 mL

TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.

Group Type: EXPERIMENTAL

TAK-954

Intervention Type: DRUG

TAK-954 intravenous infusion.

TAK-954 0.5 mg/100 mL

TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.

Group Type: EXPERIMENTAL

TAK-954

Intervention Type: DRUG

TAK-954 intravenous infusion.

TAK-954 0.1 mg/100 mL + Placebo

TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.

Group Type: EXPERIMENTAL

TAK-954 Placebo

Intervention Type: DRUG

TAK-954 placebo-matching intravenous infusion.

TAK-954

Intervention Type: DRUG

TAK-954 intravenous infusion.

TAK-954 0.5 mg/100 mL + Placebo

TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.

Group Type: EXPERIMENTAL

TAK-954 Placebo

Intervention Type: DRUG

TAK-954 placebo-matching intravenous infusion.

TAK-954

Intervention Type: DRUG

TAK-954 intravenous infusion.

Interventions

TAK-954 Placebo

TAK-954 placebo-matching intravenous infusion.

Intervention Type: DRUG

TAK-954

TAK-954 intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection.

2. Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.

Exclusion Criteria

1. Has significant mechanical bowel obstruction that is not expected to resolve after the surgery, short bowel syndrome, pre-existing clinically significant GI motility disorder (example, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] greater than [>] 10 percent [%]), has an active gastric pacemaker, or requires parenteral nutrition.

2. Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).

3. Had a history of radiation therapy to the abdomen or pelvis.

5. Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).

6. Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting study drug.

7. Participant has known COVID-19 infection, or suspected COVID-19 infection.

8. Scheduled for abdominal surgery that is classified as emergency.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

University of South Alabama Medical Center

Mobile, Alabama, United States

Keck School of Medicine

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California Irvine Medical Center

Orange, California, United States

Parkview Community Hospital Medical Center

Riverside, California, United States

University of Colorado

Aurora, Colorado, United States

University of Miami Leonard M. Miller School of Medicine

Miami, Florida, United States

Center for Colon & Rectal Surgery - Altamonte Springs

Orlando, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kentucky

Lexington, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Fairview Hospital

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

HD Research Corp.

Houston, Texas, United States

North Star Medical

Houston, Texas, United States

Universitatsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitatsklinikum Mannheim

Mannheim, Baden-Wurttemberg, Germany

Klinikum Rechts der Isar der Technischen Universitat Munchen

München, Bavaria, Germany

Universitaetsklinikum Regensburg

Regensburg, Bavaria, Germany

Sankt Josef-Hospital

Bochum, North Rhine-Westphalia, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Countries

United States; Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b603a4db2bf003ab4a2cf

To obtain more information on the study, click here/on this link.

Other Identifiers

2018-003318-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1222-4784

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-954-2004

Identifier Type: -

Identifier Source: org_study_id