A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection
Status: Completed
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of South Alabama Medical Center
Mobile
California
Cedars-Sinai Medical Center
Los Angeles
Keck School of Medicine
Los Angeles
University of California Irvine Medical Center
Orange
Parkview Community Hospital Medical Center
Riverside
Colorado
University of Colorado
Aurora
Florida
University of Miami Leonard M. Miller School of Medicine
Miami
Center for Colon & Rectal Surgery - Altamonte Springs
Orlando
Cleveland Clinic Florida
Weston
Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis
Kentucky
University of Kentucky
Lexington
Louisiana
Ochsner Medical Center
New Orleans
Massachusetts
University of Massachusetts Memorial Medical Center
Worcester
New York
Stony Brook University Hospital
Stony Brook
Ohio
Fairview Hospital
Cleveland
The Ohio State University Wexner Medical Center
Columbus
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey
Texas
HD Research Corp.
Houston
North Star Medical
Houston
Other Locations
Germany
Sankt Josef-Hospital
Bochum
Universitatsklinikum Freiburg
Freiburg
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
Universitatsklinikum Mannheim
Mannheim
Klinikum Rechts der Isar der Technischen Universitat Munchen
Munchen
Universitaetsklinikum Regensburg
Regensburg
Time Frame
Start Date: 2019-03-07
Completion Date: 2022-05-27
Participants
Target number of participants: 209
Treatments
Placebo_comparator: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Authors
Sponsors
Collaborators: Takeda Development Center Americas, Inc.
Leads: Takeda