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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02660372 | Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia | PHASE3 | COMPLETED | 210 | — | — | Feb 1, 2016 | Dec 1, 2016 | Dec 15, 2016 | 1 | Russia |
Specific questionnaire with a 4 point scale
| Arm | Type | Description |
|---|---|---|
| Imonogas | EXPERIMENTAL | Imonogas 120 mg, 1 capsule three times daily for 8 weeks |
| Espumisan | ACTIVE_COMPARATOR | Espumisan 40 mg, 2 capsules four times daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| Imonogas | DRUG | Simethicone 120 mg in gel capsules |
| Espumisan | DRUG | Simethicone 40 mg in gel capsules |
Inclusion Criteria: 1. Subjects of the age of 18 years or older with a suspected diagnosis of functional dyspepsia according to Rome III criteria (see Appendix A) e.g. subjects suffering from bothersome postprandial fullness or early satiation or epigastric pain or epigastric burning AND no evidenc...