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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003318-42 | EudraCT Number | ||
| U1111-1222-4784 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-954 Placebo | Drug | TAK-954 placebo-matching intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator | The time from the end of surgery (time the incision is closed) until ready for discharge was defined as time from end of surgery until the participant presented effective intestinal transit (spontaneous bowel movement), tolerated solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, had satisfactory pain control with oral analgesics, and was medically stable/free of complications. Kaplan-Meier survival analysis method was used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 30617 | United States | ||
| Keck School of Medicine |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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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.
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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.
Participants with a diagnosis of postoperative gastrointestinal dysfunction were enrolled in a 1:1:1:1:1 ratio into one of the five treatment groups to receive TAK-954 and/or placebo before and after surgery.
Participants took part in the study at 20 investigative sites in Germany and the United States from 07 March 2019 to 27 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 gastrointestinal (GI) function or for up to 10 days. |
| FG001 | TAK-954 0.1 mg/100 mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2021 | May 26, 2023 |
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|
| TAK-954 | Drug | TAK-954 intravenous infusion. |
|
| Day 1 (surgery) up to Day 24 |
| Time From the End of Surgery Until the Discharge Order is Written | Kaplan-Meier survival analysis method was used. | Day 1 (surgery) up to Day 24 |
| Time From the End of Surgery to Discharge From Hospital | Kaplan-Meier survival analysis method was used. | Day 1 (surgery) up to Day 24 |
| Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | The time from end of surgery to tolerance of solid food was defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal. Kaplan-Meier survival analysis method was used. | Day 1 (surgery) up to Day 10 postsurgery |
| Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | The time from end of surgery to first spontaneous bowel movement was defined as a stool not induced by the use of enemas or laxatives. Kaplan-Meier survival analysis method was used. | Day 1 (surgery) up to Day 10 postsurgery |
| Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 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. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis. | Day 1 (surgery) up to Day 10 |
| Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | Participants who required insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery were observed. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis. | 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) |
| Time From End of Surgery to First Flatus | Kaplan-Meier survival analysis method was used. | 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 | Day 1 (surgery): postinfusion |
| Los Angeles |
| California |
| 90007 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| Parkview Community Hospital Medical Center | Riverside | California | 92504 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Miami Leonard M. Miller School of Medicine | Miami | Florida | 33136 | United States |
| Center for Colon & Rectal Surgery - Altamonte Springs | Orlando | Florida | 32804 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| HD Research Corp. | Houston | Texas | 77024 | United States |
| North Star Medical | Houston | Texas | 77089 | United States |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitatsklinikum Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Klinikum Rechts der Isar der Technischen Universitat Munchen | München | Bavaria | 81675 | Germany |
| Universitaetsklinikum Regensburg | Regensburg | Bavaria | 93053 | Germany |
| Sankt Josef-Hospital | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Safety Set | Safety Set included all participants who were randomized and received at least 1 dose of double-blind study medication. |
|
| Full Analysis Set (FAS) | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). |
|
| Pharmacokinetic (PK) Analysis Set | PK Analysis Set included all participants who were randomized, received at least 1 dose and had at least 1 measurable post-dose plasma for TAK-954. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized Set included all participants who were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | TAK-954 placebo-matching, 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. |
| BG001 | TAK-954 0.1 mg/100 mL | TAK-954 0.1 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Height | Number analyzed is the number of participants with data available for analysis at Baseline. | Mean | Standard Deviation | centimeters (cm) |
| |||||||||
| Weight | Number analyzed is the number of participants with data available for analysis at Baseline. | Mean | Standard Deviation | kilograms (kg) |
| |||||||||
| Body Mass Index (BMI) | BMI=[weight(kg)]/[height(m^2)] | Number analyzed is the number of participants with data available for analysis at Baseline. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Median | Full Range | days | Day 1 (surgery) up to Day 10 postsurgery |
|
|
|
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| Secondary | Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator | The time from the end of surgery (time the incision is closed) until ready for discharge was defined as time from end of surgery until the participant presented effective intestinal transit (spontaneous bowel movement), tolerated solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, had satisfactory pain control with oral analgesics, and was medically stable/free of complications. Kaplan-Meier survival analysis method was used. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Median | Full Range | days | Day 1 (surgery) up to Day 24 |
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| Secondary | Time From the End of Surgery Until the Discharge Order is Written | Kaplan-Meier survival analysis method was used. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Median | Full Range | days | Day 1 (surgery) up to Day 24 |
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| Secondary | Time From the End of Surgery to Discharge From Hospital | Kaplan-Meier survival analysis method was used. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Median | Full Range | days | Day 1 (surgery) up to Day 24 |
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| Secondary | Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | The time from end of surgery to tolerance of solid food was defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal. Kaplan-Meier survival analysis method was used. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Median | Full Range | days | Day 1 (surgery) up to Day 10 postsurgery |
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| Secondary | Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | The time from end of surgery to first spontaneous bowel movement was defined as a stool not induced by the use of enemas or laxatives. Kaplan-Meier survival analysis method was used. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Median | Full Range | days | Day 1 (surgery) up to Day 10 postsurgery |
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| Secondary | Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 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. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Number | percentage of participants | Day 1 (surgery) up to Day 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | Participants who required insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery were observed. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Number | percentage of participants | 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) |
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| Secondary | Time From End of Surgery to First Flatus | Kaplan-Meier survival analysis method was used. | FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline on-treatment primary efficacy evaluation (bowel movement or tolerating solid food). | Posted | Median | Full Range | days | Day 1 (surgery) up to first flatus (up to Day 10 postsurgery) |
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| Secondary | Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 | PK Analysis Set included all participants who were randomized, received at least 1 dose and had at least 1 measurable post-dose plasma for TAK-954. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Day 1 (surgery): postinfusion |
|
From first dose of study drug up to Day 100
All-cause Mortality: All participants enrolled in the study. Serious and Other Adverse Events: Safety Set included all participants who were randomized and received at least 1 dose of double-blind study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 gastrointestinal (GI) function or for up to 10 days. | 0 | 52 | 8 | 49 | 46 | 49 |
| EG001 | 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. | 0 | 27 | 9 | 26 | 23 | 26 |
| EG002 | 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. | 0 | 51 | 8 | 48 | 39 | 48 |
| EG003 | 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. | 0 | 27 | 2 | 25 | 21 | 25 |
| EG004 | 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. | 1 | 52 | 11 | 50 | 41 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dehiscence | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Postoperative delirium | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urinoma | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2021 | May 26, 2023 | SAP_001.pdf |
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| Wald chi-square test | =0.505 | P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio>1. | Hazard Ratio (HR) | 1.00 | 2-Sided | 90 | 0.69 | 1.43 | Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable. | Superiority |
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. |
| OG003 | 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. |
| OG004 | 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. |
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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. |
| OG004 | 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. |
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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. |
| OG004 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
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| OG003 | 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. |
| OG004 | 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. |
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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.
| OG003 | 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. |
| OG004 | 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. |
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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. |
| OG004 | 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. |
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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. |
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