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

NCT03827655 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: TAK-954-20042018-003318-42U1111-1222-4784
• Study Type: interventional
• Target: 209
• Locations: 2 countries
• Sites: 25

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.

Conditions

Postoperative Gastrointestinal Dysfunction

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator

  The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.

  Day 1 (surgery) up to Day 10 postsurgery

Secondary Outcomes (9)

• Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator

  Day 1 (surgery) up to Day 24

• Time From the End of Surgery Until the Discharge Order is Written

  Day 1 (surgery) up to Day 24

• Time From the End of Surgery to Discharge From Hospital

  Day 1 (surgery) up to Day 24

• Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator

  Day 1 (surgery) up to Day 10 postsurgery

• Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator

  Day 1 (surgery) up to Day 10 postsurgery

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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.

Drug: TAK-954 Placebo

TAK-954 0.1 mg/100 mL

EXPERIMENTAL

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.

Drug: TAK-954

TAK-954 0.5 mg/100 mL

EXPERIMENTAL

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.

Drug: TAK-954

TAK-954 0.1 mg/100 mL + Placebo

EXPERIMENTAL

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.

Drug: TAK-954 Placebo; Drug: TAK-954

TAK-954 0.5 mg/100 mL + Placebo

EXPERIMENTAL

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.

Drug: TAK-954 Placebo; Drug: TAK-954

Interventions

TAK-954 Placebo DRUG

TAK-954 placebo-matching intravenous infusion.

Placebo; TAK-954 0.1 mg/100 mL + Placebo; TAK-954 0.5 mg/100 mL + Placebo

TAK-954 DRUG

TAK-954 intravenous infusion.

TAK-954 0.1 mg/100 mL; TAK-954 0.1 mg/100 mL + Placebo; TAK-954 0.5 mg/100 mL; TAK-954 0.5 mg/100 mL + Placebo

Eligibility Criteria

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

You may qualify if:

• Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection.
• Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.

You may not qualify if:

• 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.
• Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
• Had a history of radiation therapy to the abdomen or pelvis.
• 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).
• Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting study drug.
• Participant has known COVID-19 infection, or suspected COVID-19 infection.
• Scheduled for abdominal surgery that is classified as emergency.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (25)

University of South Alabama Medical Center

Mobile, Alabama, 30617, United States

Location

Keck School of Medicine

Los Angeles, California, 90007, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Parkview Community Hospital Medical Center

Riverside, California, 92504, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Miami Leonard M. Miller School of Medicine

Miami, Florida, 33136, United States

Location

Center for Colon & Rectal Surgery - Altamonte Springs

Orlando, Florida, 32804, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

HD Research Corp.

Houston, Texas, 77024, United States

Location

North Star Medical

Houston, Texas, 77089, United States

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitatsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Klinikum Rechts der Isar der Technischen Universitat Munchen

München, Bavaria, 81675, Germany

Location

Universitaetsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Sankt Josef-Hospital

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Links

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

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  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: January 30, 2019
• First Posted: February 1, 2019
• Study Start: March 7, 2019
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: June 23, 2023
• Results First Posted: June 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

DE (6); US (19)