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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ritter Pharmaceuticals, Inc.

Criteria

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