A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
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|ClinicalTrials.gov Identifier: NCT03827655|
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : June 7, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Gastrointestinal Dysfunction||Drug: TAK-954 Placebo Drug: TAK-954||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||March 7, 2019|
|Actual Primary Completion Date :||May 27, 2022|
|Actual Study Completion Date :||May 27, 2022|
Placebo Comparator: Placebo
TAK-954 placebo-matching, 60-minute infusion, intravenously, 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 placebo-matching intravenous infusion.
Experimental: TAK-954 0.5 mg/100 mL
TAK-954 0.5 mg/100 mL, 60-minute infusion, intravenously, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
TAK-954 intravenous infusion.
Experimental: TAK-954 0.5 mg/100 mL + Placebo
TAK-954 0.5 mg/100 mL, 60-minute infusion, intravenously, 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
TAK-954 placebo-matching intravenous infusion.
TAK-954 intravenous infusion.
- Time From End of the Surgery to Resolution of Upper and Lower GI Function Postsurgery as Assessed by the Investigator [ Time Frame: Day 1 (surgery) up to Day 10 postsurgery ]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 occurs later up to 10 days postsurgery will be observed.
- Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator [ Time Frame: Day 1 (surgery) up to Day 10 ]The time from the end of surgery (time the incision is closed) until ready for discharge is defined as time from end of surgery until the participant presents effective intestinal transit (spontaneous bowel movement), tolerates solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, has satisfactory pain control with oral analgesics, and is medically stable/free of complications.
- Time From the End of Surgery Until the Discharge Order is Written [ Time Frame: Day 1 (surgery) until day discharged (approximately 10 days postsurgery) ]
- Time From the End of Surgery to Discharge From Hospital [ Time Frame: Day 1 (surgery) until day discharged (approximately 10 days postsurgery) ]
- Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator [ Time Frame: Day 1 (surgery) up to Day 10 postsurgery ]The time from end of surgery to tolerance of solid food is defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal.
- Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator [ Time Frame: Day 1 (surgery) up to Day 10 postsurgery ]The time from end of surgery to first spontaneous bowel movement is defined as a stool not induced by the use of enemas or laxatives.
- Percentage of Participants with Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator [ Time Frame: Day 1 (surgery) up to Day 10 ]Participants unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of nasogastric (NG) tube at or after 5 days post-surgery.
- Percentage of Participants Requiring Insertion of NG Tube Postsurgery [ Time Frame: Day 1 (surgery) up to Day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms) ]Participants who would require insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery will be observed.
- Time From End of Surgery to First Flatus [ Time Frame: Day 1 (surgery) up to first flatus (up to Day 10 postsurgery) ]
- Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 [ Time Frame: Day 1 (surgery): preinfusion and postinfusion ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- Scheduled to undergo any of the following surgeries: low anterior resection, total or subtotal colectomy, colostomy, ileostomy or reversal of stoma, or has a diagnosis that requires rectal resection (eg, tumors in the anorectum) and will likely require lower anterior resection surgery. Participants with planned surgery for which there is no anticipated significant rectal resection and is, therefore, likely to preserve anorectal function and continence postsurgery, will likely be eligible for inclusion in the study if they meet all the study inclusion/exclusion criteria (eg, participants with lesions not involving the rectum [sigmoid colon and above]).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827655
|Study Director:||Study Director||Takeda|
|Other Study ID Numbers:||
2018-003318-42 ( EudraCT Number )
U1111-1222-4784 ( Registry Identifier: WHO )
|First Posted:||February 1, 2019 Key Record Dates|
|Last Update Posted:||June 7, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|