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
Bruce Robb, MD
Primary Investigator
Brief description of study
This randomized, placebo-controlled, parallel 5-group, double-blind study is designed to determine: (1) if the drug TAK-954 decreases the duration of gastrointestinal (GI) dysfunction in patients undergoing major abdominal open or laparoscopic-assisted surgeries that involve significant bowel manipulation, (2) whether preoperative dosing alone or a preoperative and postoperative dosing regimen is the most effective dosing regimen to decrease the duration of postoperative GI dysfunction (POGD) and improve clinical outcomes, and (3) the most appropriate dose and dosing regimen to advance into phase 3.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Large-Bowel Resection, Small-Bowel Resection
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria
Scheduled to undergo a laparoscopic-assisted, or open partial small- or large-bowel, resection.
A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and for up to 30 days posttreatment.
Exclusion Criteria
Has received any investigational compound within 30 days prior to screening.
Has received TAK-954 in a previous clinical study or as a therapeutic agent.
An immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Has significant mechanical bowel obstruction that is not expected to resolve after the surgery, short bowel syndrome, pre-existing clinically significant GI motility disorder (eg, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] >10%), has an active gastric pacemaker, or requires parenteral nutrition.
Had previous major abdominal surgery (eg, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
Has 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.
