Lactose Intolerance Clinical Trial
Official title:
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
Ritter Pharmaceuticals, Inc. is developing RP G28 as a treatment for Lactose Intolerance. Lactose intolerance is a syndrome of gastrointestinal symptoms resulting from a deficiency in intestinal lactase relative to the amount of lactose consumed. Efficacy of RP-G28 will be evaluated by the reduction of lactose intolerance-associated symptoms. The primary objective of this study is to assess the efficacy of RP G28 compared to placebo on symptom reduction related to lactose intolerance.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study
conducted in the United States (US). The study is comprised of 6 study periods divided into
Part A and Part B.
- Part A includes a 14-day Screening Period to determine eligibility including baseline
daily lactose consumption, daily symptom assessment, and a 1-week placebo run-in, a
30-day double-blind Treatment Period (no dairy consumption), a 30-day Real World
Experience Period to assess study drug response (dairy allowed ad libitum), and a
2-month added Durability Period (dairy allowed ad libitum).
- Part B is contiguous with (ie, begins immediately after) Part A and includes a blinded
re-randomization to a 30-day Retreatment Period (no dairy consumption) followed by a
7-day Real World Experience Period (dairy allowed ad libitum).
Throughout the study, patients will undergo blinded Solution Z Assessment (SZA)/lactose
challenges and patient reported outcome (PRO) assessments.
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