Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance

Study Overview
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Brief Summary
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This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.

Detailed Description
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Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming too much 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/cramps, 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. 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. This study will evaluate a treatment that provides a simplified dosing regimen as well as the potential for extended relief from symptoms following a limited therapy regimen.

Official Title
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Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effectiveness, Safety and Tolerability of RP-G28 in Subjects With Symptoms Associated With Lactose Intolerance

Conditions
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Lactose Intolerance

Intervention / Treatment
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* Drug: RP-G28 or placebo
* Drug: RP-G28 or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects. Female subjects must be non-pregnant and non-lactating. 18 to 64 years of age inclusive at Screening Current or recent history of intolerance to milk and other dairy products Acceptable Baseline Lactose Intolerance Symptom Scores Acceptable Result on Baseline Hydrogen Breath Test Subjects must agree to refrain from all other treatments and products used for lactose intolerance during the study Exclusion Criteria: Disorders known to be associated with abnormal GI motility History of surgery that alters the normal function of the gastrointestinal tract Past or present; organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS) Active gastric or duodenal ulcers or history of severe ulcers Diabetes mellitus (type 1 or type 2) Congestive Heart Failure History of Human Immunodeficiency Virus (HIV), Hepatitis B or C Use of concurrent therapy(ies) for symptoms of lactose intolerance Uncontrolled BP defined as sitting systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥95 mmHg at Visit 1 History of ethanol abuse in the past 12 months History of drug abuse within 12 months History or presence of malignancy within the past 5 years (except basal cell or squamous cell carcinoma removed from a sun-exposed area) Use of any investigational drug or participation in any investigational study within 30 days prior to Screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RP-G28<br>Study Drug RP-G28 | Drug: RP-G28 or placebo<br>* Qualified subjects randomized to daily dosing with RP-G28 or placebo<br>Drug: RP-G28 or placebo<br>* Daily dosing<br>|
| Placebo Comparator: Placebo<br>Study Drug Placebo | Drug: RP-G28 or placebo<br>* Qualified subjects randomized to daily dosing with RP-G28 or placebo<br>Drug: RP-G28 or placebo<br>* Daily dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge |  | Baseline, 36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Adverse Events as Measure of Safety and Tolerability | Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | 36 days | 

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