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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00813098 | Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome | PHASE2 | COMPLETED | 155 | — | — | Dec 1, 2008 | Aug 1, 2010 | Dec 2, 2010 | 36 | United States |
The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,"In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"
| Arm | Type | Description |
|---|---|---|
| High dose | EXPERIMENTAL | A high dose of LX1031; daily oral intake for 28 days |
| Low Dose | EXPERIMENTAL | A low dose of LX1031; daily oral intake for 28 days |
| Placebo | PLACEBO_COMPARATOR | Matching placebo dosing with daily oral intake |
| Name | Type | Description |
|---|---|---|
| LX1031 High Dose | DRUG | A high dose of LX1031; daily oral intake for 28 days |
| LX1031 Low Dose | DRUG | A low dose of LX1031; daily oral intake for 28 days. |
| Placebo | DRUG | Matching placebo dosing with daily oral intake |
Inclusion Criteria: * Males and females aged 18-70 years old * Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria * Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods * Normal structural evaluation of the colon within 5 years...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Ardelyx, Inc. | ARDX | 4 | PHASE3 | Tenapanor |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Eluxadoline |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | — | Undisclosed |
| Johnson & Johnson | JNJ | 1 | — | Anti TNF therapy including infliximab, No Biologics |
| Cooper Companies, Inc. | COO | 1 | NA | Undisclosed |