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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ritter Pharmaceuticals, Inc.

Criteria

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.