Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance

Study Overview
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Brief Summary
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RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products).

Detailed Description
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Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming lactose or when lactose is added to a previously low-lactose diet. Lactose intolerance is characterized by one or more of the cardinal symptoms that follow the ingestion of lactose-containing foods. These symptoms include; abdominal pain, cramping, bloating, flatulence [gas] and diarrhea. As such, most lactose intolerant individuals avoid the ingestion of milk and dairy products, while others substitute non-lactose containing products in their diet. Currently, there are no approved treatments for this condition. Based on the health implications from insufficient calcium intake over a lifetime, including increased risk of osteoporosis and hypertension, there is need in the medical community for a tolerable and convenient treatment that allows for all levels of milk and dairy product consumption in people suffering from mild to severe lactose intolerance. Study Objective: To access efficacy of two RP-G28 dosing regimes on symptoms related to lactose intolerance relative to placebo after 30 days of treatment. The 30 day post-treatment phase will further evaluate the treatment's potential to prolong relief from symptoms. Study Design: The participants will take about 60 days to complete the study. The study consists of 3 distinct phases: Screening, a 30-day Treatment Phase, and a 30-day Post-Treatment Phase (off study treatment observation period). A participant will need to visit the clinical only 6 times throughout the study.

Official Title
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A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Two Doses of RP-G28 in Subjects With Lactose Intolerance

Conditions
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Lactose Intolerance

Intervention / Treatment
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* Drug: RP-G28
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion/Exclusion Criteria: Female subjects must be non pregnant, and non lactating. Females of childbearing potential must use adequate birth control during study participation Medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance. Must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), Celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (SIBO), active gastric or duodenal ulcers, or history of severe ulcers. Must be nicotine free.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RP-G28 Dose 1<br> | Drug: RP-G28<br>* Study drug taken orally<br>|
| Experimental: RP-G28 Dose 2<br> | Drug: RP-G28<br>* Study drug taken orally<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo taken orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in abdominal pain | Percent change from baseline to Day 31 of AUC abdominal pain symptom score based on measures taken after a lactose challenge test at 1, 2, 3, 4, and 5 hours. The method of assessment for this outcome measure is an 11-point numeric rating scale completed by the subject. | Day 31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactose maldigestion, Dairy intolerance, Intolerance to milk, Intolerance to dairy, Milk intolerance, GI disorder, Lactose metabolism, GI symptoms after dairy ingestion