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

Lactose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673749
• Other study ID #: G28-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 25, 2016
• Last updated: April 2, 2018
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: Ritter Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

Drug:
• RP-G28
Study drug taken orally

Other:
• Placebo
Placebo taken orally

Locations

Country	Name	City	State
United States	Covance, Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ritter Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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