Table 2 Primary and Secondary endpoints
Primary and Secondary endpoints | |
|---|---|
Type | Description |
Primary | Change from baseline to Day 36 in 6-hour HBT total hydrogen production; |
Primary | Change from baseline (6-hour timepoint) to Day 36 (6-hour timepoint) in lactose intolerance symptom assessment total score during lactose challenge. |
Primary-Safety | Adverse events (AEs), Vital signs, Clincal laboratory results, physical examinations |
Secondary | Change from baseline to Day 66 in 6-hour HBT total hydrogen production |
Secondary | Change from baseline (6-hour timepoint) to Day 66 (6-hour timepoint) in lactose intolerance symptom assessment total score during lactose challenge |
Secondary | Change from baseline (6-hour timepoint) to Day 36 (6-hour timepoint) in individual lactose intolerance symptom assessment categories (ie, abdominal pain, bloating, flatulence, diarrhea, and abdominal cramping) |
Secondary | Change from baseline (6-hour timepoint) to Day 66 (6-hour timepoint) in individual lactose intolerance symptom assessment categories (ie, abdominal pain, bloating, flatulence, diarrhea, and abdominal cramping) |
Secondary | Responder analysis, comparing RP-G28 group to placebo group, based on numbers (percent) of subjects achieving a 50% reduction in symptoms (total and individual scores, 6 hours) at Day 36 compared with the baseline lactose challenge and at Day 66 compared with the baseline lactose challenge |
Secondary | Patient Global Assessment |