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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01855711 | Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS) | PHASE2 | COMPLETED | 32 | — | — | Sep 18, 2003 | May 10, 2005 | May 1, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| GR68755 (Alosetron hydrochrolide) group | EXPERIMENTAL | GR68755 1 mg tablets QD in the morning every day for 28 days |
| Name | Type | Description |
|---|---|---|
| GR68755 (Alosetron hydrochloride) 1 mg tablet | DRUG | 1 tablet (1 mg) once a day |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Disease to be treated: Has been diagnosed with severe d-IBS (at least 6 months of d-IBS symptoms as defined by the Rome II Criteria), and failed conventional IBS therapy. ...