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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02365701 | Study of Motilitone to Treat Functional Dyspepsia | PHASE2 | COMPLETED | 45 | — | — | Jun 1, 2015 | Feb 1, 2018 | May 21, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Motilitone 30mg | EXPERIMENTAL | Motilitone will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo (same formulation as Motilitone but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Motilitone 30mg | DRUG | 30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks |
| Placebo | DRUG | Placebo, in tablet form, to be taken 3 times daily for 4 weeks. The placebo is the same formulation as Motilitone except that it does not contain the active pharmaceutical ingredient. |
Inclusion Criteria: * (1) Subject fulfilling Rome III criteria for Functional Dyspepsia: They must have one or more of the following: 1. Bothersome postprandial fullness 2. Early satiation 3. Epigastric pain 4. Epigastric burning AND No evidence of structural disease at upper endoscopy wit...