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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00871325
Other study ID # TU100CPT1
Secondary ID
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


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
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