Phase 2
N=209
A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
Postoperative Gastrointestinal Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03827655 ↗Enrolled (actual)
209
Serious AEs
19.2%
Results posted
Jun 2023
Primary outcome: Primary: Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator — 1.89; 2.76; 2.59; 2.62 days — p==0.649
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAK-954 Placebo (Drug); TAK-954 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator |
1.89; 2.76; 2.59; 2.62; 2.58 | =0.649 |
| SECONDARY Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator |
2.03; 2.82; 2.69; 2.94; 2.77 | =0.449 |
| SECONDARY Time From the End of Surgery Until the Discharge Order is Written |
2.86; 3.95; 2.81; 2.94; 3.33 | =0.406 |
| SECONDARY Time From the End of Surgery to Discharge From Hospital |
2.96; 4.06; 2.89; 3.05; 3.39 | =0.446 |
| SECONDARY Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator |
1.82; 2.76; 2.36; 2.15; 2.55 | =0.760 |
| SECONDARY Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator |
1.56; 1.73; 1.11; 1.72; 1.74 | =0.288 |
| SECONDARY Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator |
8.9; 8.7; 2.4; 4.8; 9.1 | =0.046 sig |
| SECONDARY Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery |
8.9; 0.0; 4.8; 4.8; 11.4 | =0.296 |
| SECONDARY Time From End of Surgery to First Flatus |
1.21; 1.26; 0.96; 1.18; 1.12 | =0.338 |
| SECONDARY Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1 |
1190; 5220; 2500; 12000 | — |
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 Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03827655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.