Clinical Trial: A Tolerability and Efficacy Study of TU-100 For The Treatment of Postoperative Ileus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Controlled, Open-Label Tolerability And Efficacy Study Of TU-100 For The Treatment Of Postoperative Ileus In Patients Undergoing Laparotomy For Large Bowel R

Brief Summary:

Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly occurs in patients who have undergone abdominal surgery and contributes to postoperative morbidity, including delayed enteral nutrition, increased patient discomfort, and prolonged hospitalization. POI appears to be have many causes, with activation of inhibitory reflexes, inflammatory responses, and the effects of anesthesia and analgesics all playing roles. However, there is no approved pharmacological therapy for the treatment and prevention of POI.

Daikenchuto (TU-100) is an herbal formulation consisting of Asian ginseng, Zanthoxylum fruit (Sichuan pepper), ginger, and malt sugar, which was originally described in Jin kui yao lue, the classical medical textbook written in ancient China in the third century by Zhang Zhong Jing. Since it was introduced to Japan, Daikenchuto has been used in the treatment of abdominal pain and a feeling of coldness in the abdomen.

TSUMURA Daikenchuto Extract Granules, Product Code TU-100, is a modern herbal product manufactured in the dosage form of granules by Tsumura & Co. The current Tsumura product, TU-100, was approved for manufacture as a prescription drug in 1986 by the Japanese Ministry of Health and Welfare and has been sold commercially as a prescription Kampo (a generic term for the system of traditional medicine that was developed in Japan after being introduced from China in the fourth century) drug in Japan for many years. The drug product proposed for use in the clinical studies is identical to the drug currently sold in Japan. In addition, all three botanical components and maltose syrup powder are considered as food substances and are currently part of the United States food supply.

The purpose of this study evaluate the toler

Detailed Summary: This is a randomized, controlled, open-label study designed to evaluate the tolerability and efficacy of TU-100 for the treatment of POI in patients undergoing laparotomy for large bowel resection. It will be conducted at multiple centers in the United States. A total of 24 patients will be enrolled in the study. Patient participation in the study will last for up to 32 days (from Screening to postoperative day 10 [POD 10] or until the time when a discharge order is written for the patient, whichever comes first), with follow-up safety assessments to occur 7 and 14 days after the last dose of study medication.
Sponsor: Tsumura USA

Current Primary Outcome: Evaluate the tolerability of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection based on the incidence of adverse events (AEs). [ Time Frame: Up to 10 days ]

Original Primary Outcome: Evaluate the tolerability of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection based on the incidence of adverse events (AEs).

Current Secondary Outcome:

  • To evaluate the safety of TU-100 in the treatment of POI based on an assessment of objective and subjective symptoms and clinical laboratory data [ Time Frame: Up to 10 days ]
  • To evaluate the efficacy of TU-100 in the treatment of POI based on the length of time from the end of surgery to gastrointestinal(GI) function recovery and time to discharge order, and [ Time Frame: Up to 10 days ]
  • To determine the acceptability of TU-100 to American patients based on the number of discontinuations due to noncompliance and an assessment of taste. [ Time Frame: Up to 10 days ]


Original Secondary Outcome:

  • 1. To evaluate the safety of TU-100 in the treatment of POI based on an assessment of objective and subjective symptoms and clinical laboratory data
  • 2. To evaluate the efficacy of TU-100 in the treatment of POI based on the length of time from the end of surgery to gastrointestinal(GI) function recovery and time to discharge order, and
  • 3. To determine the acceptability of TU-100 to American patients based on the number of discontinuations due to noncompliance and an assessment of taste.


Information By: Tsumura USA

Dates:
Date Received: December 14, 2005
Date Started: December 2005
Date Completion:
Last Updated: July 11, 2013
Last Verified: June 2012