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

This study has been completed.
Sponsor:
Collaborator:
Cato Research
Information provided by (Responsible Party):
Tsumura USA
ClinicalTrials.gov Identifier:
NCT00871325
First received: March 26, 2009
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Postoperative Ileus
Drug: Daikenchuto (TU-100)
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans

Further study details as provided by Tsumura USA:

Primary Outcome Measures:
  • Gastric emptying of solid [ Time Frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs ] [ Designated as safety issue: No ]
  • Colonic geometric center at 24 hours [ Time Frame: 4 hrs, 8 hrs, and 24 hrs ] [ Designated as safety issue: No ]
  • Ascending colon emptying [ Time Frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Colonic geometric center at 4 hours and 48 hours [ Time Frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs ] [ Designated as safety issue: No ]
  • Colonic filling at 6 hours [ Time Frame: 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs ] [ Designated as safety issue: No ]
  • Stool frequency [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5 ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daikenchuto (TU-100) 7.5g/day
Daikenchuto (TU-100) 2.5g TID (7.5g/day)
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.
Experimental: Daikenchuto (TU-100) 15g/day
Daikenchuto (TU-100) 5g TID (15g/day)
Drug: 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 Comparator: Placebo
Placebo TID
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871325

Locations
United States, Minnesota
Mayo Clinic, Rochester Methodist CRU
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Tsumura USA
Cato Research
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic, Rochester Methodist CRU
  More Information

No publications provided

Responsible Party: Tsumura USA
ClinicalTrials.gov Identifier: NCT00871325     History of Changes
Other Study ID Numbers: TU100CPT1
Study First Received: March 26, 2009
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tsumura USA:
Gastric emptying
Small bowel transit
Colonic transit
Whole gut transit
Postoperative Ileus

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014