Trials / Completed
CompletedNCT00871325
Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans
Effect of Gastrointestinal Nerve Modulation With DAIKENCHUTO (TU-100) on Gastrointestinal and Colonic Transit in Humans
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Tsumura USA · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-12-01
- Completion
- 2010-01-01
- First posted
- 2009-03-30
- Last updated
- 2013-01-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00871325. Inclusion in this directory is not an endorsement.