Status:
COMPLETED
Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans
Lead Sponsor:
Tsumura USA
Collaborating Sponsors:
Cato Research
Conditions:
Postoperative Ileus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 trans...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00871325
Start Date
June 1 2009
End Date
January 1 2010
Last Update
January 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic, Rochester Methodist CRU
Rochester, Minnesota, United States, 55905