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| Name | Class |
|---|---|
| Cato Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daikenchuto (TU-100) 7.5g/day | Experimental | Daikenchuto (TU-100) 2.5g TID (7.5g/day) |
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| Daikenchuto (TU-100) 15g/day | Experimental | Daikenchuto (TU-100) 5g TID (15g/day) |
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| Placebo | Placebo Comparator | Placebo TID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daikenchuto (TU-100) | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying of solid | 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs | |
| Colonic geometric center at 24 hours | 4 hrs, 8 hrs, and 24 hrs | |
| Ascending colon emptying | 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Colonic filling at 6 hours | 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs | |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic, Rochester Methodist CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, Rochester Methodist CRU | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| C121414 | dai-kenchu-to |
| C559645 | 12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine |
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| Daikenchuto (TU-100) | Drug | 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 | Drug | 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. |
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| Stool frequency |
| Day 1, Day 2, Day 3, Day 4, Day 5 |
| Stool consistency | Day 1, Day 2, Day 3, Day 4, Day 5 |