Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

January 31, 2010

Conditions
Postoperative Ileus
Interventions
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.

Trial Locations (1)

55905

Mayo Clinic, Rochester Methodist CRU, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cato Research

INDUSTRY

lead

Tsumura USA

INDUSTRY

NCT00871325 - Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans | Biotech Hunter | Biotech Hunter