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
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- STATUS
- Not Recruiting
Summary
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.
Details
| Condition | Large-Bowel Resection, Small-Bowel Resection |
|---|---|
| Age | 18years - 100years |
| Clinical Study Identifier | TX10413 |
| Last Modified on | 19 February 2024 |
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