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

Phase 2

Completed

• Conditions: Lactose Intolerance
• Interventions: Drug: RP-G28; Other: Placebo

• Registration Number: NCT02673749
• Lead Sponsor: Ritter Pharmaceuticals, Inc.

Brief 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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-01-25
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-04
• Disposition First Submitted: 2018-04-02
• Disposition First Submitted QC: 2018-04-02
• Last Update Submitted: 2018-04-02
• Disposition First Posted: 2018-04-04
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RP-G28 Dose 1	RP-G28	-
RP-G28 Dose 2	RP-G28	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in abdominal pain	Day 31	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.

Trial Locations

Locations (1)

Covance, Inc.; 🇺🇸 Princeton, New Jersey, United States