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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05556824 | Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD | PHASE2 | ACTIVE NOT_RECRUITING | 247 | — | — | Mar 3, 2023 | May 1, 2026 | Mar 25, 2026 | 18 | United States |
The difference between baseline weekly average heartburn-free days and weekly average heartburn-free days during Treatment Phase Weeks 1-4 and Weeks 5-8 (as measured using questions 1, 2 and 3 of the Reflux Symptom Questionnaire Electronic Diary) (RESQ-eD).
| Arm | Type | Description |
|---|---|---|
| Drug Product | ACTIVE_COMPARATOR | Panosyl-isomaltooligosaccharide (PIMO) liquid 1 g (1.5 ml) per day for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo liquid (1.5 ml) per day for 8 weeks |
| Name | Type | Description |
|---|---|---|
| MHS-1031 | DRUG | Study medication will be supplied as a syrup in individual sachets containing 1g (1.5 mL) of MHS-1031. Subjects will be randomized in 2:1 fashion to either study drug (2) or placebo (1) |
| Placebo | OTHER | Matching placebo is an oral solution formulated to have a degree of sweetness and acidity similar to the study medication and will be provided in equivalent sachets containing 1.5g (1.5 mL) of the oral placebo solution. |
Inclusion Criteria: * In the opinion of the investigator or sub-investigators, the subject is capable of understanding and complying with protocol requirements, including compliance with completing nightly online questionnaires in one of the IRB-approved languages. * Subject signs and dates an elec...