NCT01139216 - Effect of TU-100 on Rectal Compliance, Rectal Sensation and Small Bowel and Colonic Transit in Females With Constipation | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions

Functional ConstipationGastric EmptyingWhole Gut TransitSmall Bowel TransitColonic TransitRectal ComplianceRectal Sensation

Interventions

DRUG

Daikenchuto (TU-100)

Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.

DRUG

Daikenchuto (TU-100)

Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.

DRUG

Placebo

Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.

Trial Locations (1)

Mayo Clinic, Rochester Methodist CRU, Rochester