Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02074579 | A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome | PHASE2 | COMPLETED | 101 | — | — | Jul 1, 2014 | Apr 1, 2016 | May 2, 2017 | 1 | United States |
Change in abdominal bloating rating, through comparison of the change in average ratings from the 7 days prior to baseline (Visit 2) to the last 7 days of the 4 week treatment period (Visit 4), between TU-100 15 g and placebo.
| Arm | Type | Description |
|---|---|---|
| TU-100 | EXPERIMENTAL | 15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily) |
| Matching placebo | PLACEBO_COMPARATOR | Matching placebo given 5g three times daily orally for 4 consecutive weeks |
| Name | Type | Description |
|---|---|---|
| TU-100 | DRUG | 15g daily, orally as 5g three times daily for 4 consecutive weeks |
| Placebo | DRUG | Matching placebo given 5g three times daily orally for 4 consecutive weeks |
Inclusion Criteria: * Meet Rome III criteria for IBS (any subtype) * Female aged 18 to 65 years, inclusive * If of childbearing potential, prepared to use suitable forms of contraception throughout the study and for 30 days after the last dose i.e., hormonal contraceptives (such as oral contracepti...