Postoperative Gastrointestinal Dysfunction
Conditions
Keywords
Drug Therapy
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).
Interventions
DRUGTAK-954 Placebo
TAK-954 placebo-matching intravenous infusion.
DRUGTAK-954
TAK-954 intravenous infusion.
Sponsors
Takeda Development Center Americas, Inc.
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 4. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator | 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 occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From the End of Surgery Until the Discharge Order is Written | Day 1 (surgery) up to Day 24 | Kaplan-Meier survival analysis method was used. |
| Time From the End of Surgery to Discharge From Hospital | Day 1 (surgery) up to Day 24 | Kaplan-Meier survival analysis method was used. |
| Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | Day 1 (surgery) up to Day 10 postsurgery | 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. |
| Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | Day 1 (surgery) up to Day 10 postsurgery | 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. |
| 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 | 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. |
| Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | 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 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. |
| Time From End of Surgery to First Flatus | Day 1 (surgery) up to first flatus (up to Day 10 postsurgery) | Kaplan-Meier survival analysis method was used. |
| Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 | Day 1 (surgery): postinfusion | — |
| Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 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. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis. |
Countries
Germany, United States
Participant flow
Recruitment details
Participants took part in the study at 20 investigative sites in Germany and the United States from 07 March 2019 to 27 May 2022.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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. | 27 |
| 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. | 51 |
| 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. | 27 |
| 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. | 52 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Deviation | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Reason not Specified | 3 | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | TAK-954 0.1 mg/100 mL | TAK-954 0.5 mg/100 mL | TAK-954 0.1 mg/100 mL + Placebo | TAK-954 0.5 mg/100 mL + Placebo |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 13.66 | 57.9 years STANDARD_DEVIATION 11.99 | 55.9 years STANDARD_DEVIATION 13.83 | 57.3 years STANDARD_DEVIATION 14.1 | 53.7 years STANDARD_DEVIATION 12.15 | 53.2 years STANDARD_DEVIATION 15.28 |
| Body Mass Index (BMI) | 28.93 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 6.206 | 29.84 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 5.92 | 27.80 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 6.492 | 29.45 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 5.465 | 27.60 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 6.904 | 28.76 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 6.652 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 161 Participants | 43 Participants | 21 Participants | 37 Participants | 21 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 38 Participants | 8 Participants | 5 Participants | 11 Participants | 4 Participants | 10 Participants |
| Height | 172.09 centimeters (cm) STANDARD_DEVIATION 9.972 | 170.83 centimeters (cm) STANDARD_DEVIATION 10.991 | 173.01 centimeters (cm) STANDARD_DEVIATION 9.273 | 172.30 centimeters (cm) STANDARD_DEVIATION 9.335 | 172.23 centimeters (cm) STANDARD_DEVIATION 10.972 | 172.60 centimeters (cm) STANDARD_DEVIATION 9.603 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 5 Participants | 2 Participants | 0 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants | 8 Participants | 5 Participants | 9 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) White | 153 Participants | 37 Participants | 18 Participants | 42 Participants | 18 Participants | 38 Participants |
| Region of Enrollment Germany | 36 Participants | 8 Participants | 5 Participants | 9 Participants | 4 Participants | 10 Participants |
| Region of Enrollment United States | 173 Participants | 44 Participants | 22 Participants | 42 Participants | 23 Participants | 42 Participants |
| Sex: Female, Male Female | 101 Participants | 32 Participants | 10 Participants | 21 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 108 Participants | 20 Participants | 17 Participants | 30 Participants | 15 Participants | 26 Participants |
| Weight | 85.73 kilograms (kg) STANDARD_DEVIATION 19.587 | 87.25 kilograms (kg) STANDARD_DEVIATION 19.317 | 82.92 kilograms (kg) STANDARD_DEVIATION 18.066 | 87.26 kilograms (kg) STANDARD_DEVIATION 15.995 | 82.84 kilograms (kg) STANDARD_DEVIATION 26.018 | 85.64 kilograms (kg) STANDARD_DEVIATION 20.416 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 27 | 0 / 51 | 0 / 27 | 1 / 52 |
| other Total, other adverse events | 46 / 49 | 23 / 26 | 39 / 48 | 21 / 25 | 41 / 50 |
| serious Total, serious adverse events | 8 / 49 | 9 / 26 | 8 / 48 | 2 / 25 | 11 / 50 |
Outcome results
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.
Time frame: Day 1 (surgery) up to Day 10 postsurgery
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator | 1.89 days |
| TAK-954 0.1 mg/100 mL | Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator | 2.76 days |
| TAK-954 0.5 mg/100 mL | Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator | 2.59 days |
| TAK-954 0.1 mg/100 mL + Placebo | Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator | 2.62 days |
| TAK-954 0.5 mg/100 mL + Placebo | Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator | 2.58 days |
p-value: =0.64990% CI: [0.63, 1.33]Wald chi-square test
p-value: =0.50590% CI: [0.69, 1.43]Wald chi-square test
Secondary
Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1
Time frame: Day 1 (surgery): postinfusion
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 | 1190 picograms per milliliter (pg/mL) | Standard Deviation 480 |
| TAK-954 0.1 mg/100 mL | Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 | 5220 picograms per milliliter (pg/mL) | Standard Deviation 1810 |
| TAK-954 0.5 mg/100 mL | Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 | 2500 picograms per milliliter (pg/mL) | Standard Deviation 4140 |
| TAK-954 0.1 mg/100 mL + Placebo | Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 | 12000 picograms per milliliter (pg/mL) | Standard Deviation 28500 |
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.
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)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | 8.9 percentage of participants |
| TAK-954 0.1 mg/100 mL | Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | 0.0 percentage of participants |
| TAK-954 0.5 mg/100 mL | Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | 4.8 percentage of participants |
| TAK-954 0.1 mg/100 mL + Placebo | Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | 4.8 percentage of participants |
| TAK-954 0.5 mg/100 mL + Placebo | Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery | 11.4 percentage of participants |
p-value: =0.29690% CI: [-0.12, 0.06]Stratified Miettinen and Nurminen
p-value: =0.67790% CI: [-0.07, 0.13]Stratified Miettinen and Nurminen
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.
Time frame: Day 1 (surgery) up to Day 10
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 8.9 percentage of participants |
| TAK-954 0.1 mg/100 mL | Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 8.7 percentage of participants |
| TAK-954 0.5 mg/100 mL | Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 2.4 percentage of participants |
| TAK-954 0.1 mg/100 mL + Placebo | Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 4.8 percentage of participants |
| TAK-954 0.5 mg/100 mL + Placebo | Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator | 9.1 percentage of participants |
p-value: =0.04690% CI: [-0.17, 0]Stratified Miettinen and Nurminen
p-value: =0.51690% CI: [-0.11, 0.11]Stratified Miettinen and Nurminen
Secondary
Time From End of Surgery to First Flatus
Kaplan-Meier survival analysis method was used.
Time frame: Day 1 (surgery) up to first flatus (up to Day 10 postsurgery)
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From End of Surgery to First Flatus | 1.21 days |
| TAK-954 0.1 mg/100 mL | Time From End of Surgery to First Flatus | 1.26 days |
| TAK-954 0.5 mg/100 mL | Time From End of Surgery to First Flatus | 0.96 days |
| TAK-954 0.1 mg/100 mL + Placebo | Time From End of Surgery to First Flatus | 1.18 days |
| TAK-954 0.5 mg/100 mL + Placebo | Time From End of Surgery to First Flatus | 1.12 days |
p-value: =0.33890% CI: [0.76, 1.57]Wald chi-square test
p-value: =0.42290% CI: [0.73, 1.49]Wald chi-square test
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.
Time frame: Day 1 (surgery) up to Day 10 postsurgery
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | 1.56 days |
| TAK-954 0.1 mg/100 mL | Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | 1.73 days |
| TAK-954 0.5 mg/100 mL | Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | 1.11 days |
| TAK-954 0.1 mg/100 mL + Placebo | Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | 1.72 days |
| TAK-954 0.5 mg/100 mL + Placebo | Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator | 1.74 days |
p-value: =0.28890% CI: [0.78, 1.64]Wald chi-square test
p-value: =0.45390% CI: [0.72, 1.47]Wald chi-square test
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.
Time frame: Day 1 (surgery) up to Day 10 postsurgery
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | 1.82 days |
| TAK-954 0.1 mg/100 mL | Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | 2.76 days |
| TAK-954 0.5 mg/100 mL | Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | 2.36 days |
| TAK-954 0.1 mg/100 mL + Placebo | Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | 2.15 days |
| TAK-954 0.5 mg/100 mL + Placebo | Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator | 2.55 days |
p-value: =0.7690% CI: [0.6, 1.23]Wald chi-square test
p-value: =0.8190% CI: [0.58, 1.18]Wald chi-squared test
Secondary
Time From the End of Surgery to Discharge From Hospital
Kaplan-Meier survival analysis method was used.
Time frame: Day 1 (surgery) up to Day 24
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From the End of Surgery to Discharge From Hospital | 2.96 days |
| TAK-954 0.1 mg/100 mL | Time From the End of Surgery to Discharge From Hospital | 4.06 days |
| TAK-954 0.5 mg/100 mL | Time From the End of Surgery to Discharge From Hospital | 2.89 days |
| TAK-954 0.1 mg/100 mL + Placebo | Time From the End of Surgery to Discharge From Hospital | 3.05 days |
| TAK-954 0.5 mg/100 mL + Placebo | Time From the End of Surgery to Discharge From Hospital | 3.39 days |
p-value: =0.44690% CI: [0.72, 1.48]Wald chi-square test
p-value: =0.89290% CI: [0.53, 1.09]Wald chi-square test
Secondary
Time From the End of Surgery Until the Discharge Order is Written
Kaplan-Meier survival analysis method was used.
Time frame: Day 1 (surgery) up to Day 24
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From the End of Surgery Until the Discharge Order is Written | 2.86 days |
| TAK-954 0.1 mg/100 mL | Time From the End of Surgery Until the Discharge Order is Written | 3.95 days |
| TAK-954 0.5 mg/100 mL | Time From the End of Surgery Until the Discharge Order is Written | 2.81 days |
| TAK-954 0.1 mg/100 mL + Placebo | Time From the End of Surgery Until the Discharge Order is Written | 2.94 days |
| TAK-954 0.5 mg/100 mL + Placebo | Time From the End of Surgery Until the Discharge Order is Written | 3.33 days |
p-value: =0.40690% CI: [0.73, 1.52]Wald chi-square test
p-value: =0.8890% CI: [0.54, 1.11]Wald chi-square test
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.
Time frame: Day 1 (surgery) up to Day 24
Population: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator | 2.03 days |
| TAK-954 0.1 mg/100 mL | Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator | 2.82 days |
| TAK-954 0.5 mg/100 mL | Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator | 2.69 days |
| TAK-954 0.1 mg/100 mL + Placebo | Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator | 2.94 days |
| TAK-954 0.5 mg/100 mL + Placebo | Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator | 2.77 days |
p-value: =0.44990% CI: [0.71, 1.49]Wald chi-square test
p-value: =0.50790% CI: [0.69, 1.44]Wald chi-square test