Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans

Postoperative Ileus Clinical Trial

Official title:

Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871325
• Other study ID #: TU100CPT1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 26, 2009
• Last updated: January 8, 2013
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2013
• Source: Tsumura USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the dose related effects of orally administered TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal motility and colonic transit of solids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject is willing and able to provide written informed consent

• Males and non-pregnant, non-breastfeeding females;

• Subject is willing to undergo multiple radionuclide scans

• Subject BMI is between 18 and 35 kg/m2

• Subject has a negative urine drug screen

• Subject has screening laboratory values that are within normal range for the analyzing laboratory

Exclusion Criteria:

• Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.

• Unable to withdraw medications 48 hours prior to the study:

• Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.

• Analgesic drugs including opiates, NSAID, COX 2 inhibitors

• GABAergic agents

• Benzodiazepines

NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.

• Female subjects who are pregnant or breast feeding.

• Clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.

• History of allergic reactions to ginseng, ginger, and Sichuan pepper.

• History of lactose intolerance.

• Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.

• Subjects who have participated in another clinical study within the past 30 days.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Drug:
• Daikenchuto (TU-100)
Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
• Daikenchuto (TU-100)
Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
• Placebo
Subjects will receive daily dose of TU-100 placebo. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.

Locations

Country	Name	City	State
United States	Mayo Clinic, Rochester Methodist CRU	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Tsumura USA	Cato Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying of solid		1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs	No
Primary	Colonic geometric center at 24 hours		4 hrs, 8 hrs, and 24 hrs	No
Primary	Ascending colon emptying		1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs	No
Secondary	Colonic geometric center at 4 hours and 48 hours		1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs	No
Secondary	Colonic filling at 6 hours		1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs	No
Secondary	Stool frequency		Day 1, Day 2, Day 3, Day 4, Day 5	No
Secondary	Stool consistency		Day 1, Day 2, Day 3, Day 4, Day 5	No