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Table 2 Primary and Secondary endpoints

From: Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial

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