Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans
NCT ID: NCT00871325
Last Updated: 2013-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2009-06-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Daikenchuto (TU-100) 7.5g/day
Daikenchuto (TU-100) 2.5g TID (7.5g/day)
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) 15g/day
Daikenchuto (TU-100) 5g TID (15g/day)
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
Placebo TID
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Cato Research
INDUSTRY
Tsumura USA
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Camilleri, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Rochester Methodist CRU
Locations
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Mayo Clinic, Rochester Methodist CRU
Rochester, Minnesota, United States
Countries
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Other Identifiers
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TU100CPT1
Identifier Type: -
Identifier Source: org_study_id
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