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Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

NCT03597516•Ritter Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is 18-75 years of age, inclusive, at screening;
•Intolerance to milk and other dairy products;
•Patient agrees to refrain from all other treatments and products used for lactose intolerance, to follow diet modifications required during periods of the study that include abstinence from all dairy in some periods and consuming dairy in other periods;
•Patient meets the defined minimum lactose intolerance symptom composite score; and
•Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.

Exclusion Criteria

•Patient has a disorder associated with abnormal gastrointestinal motility such as gastroparesis (from any cause), amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, uremia, or malnutrition;
•Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation);
•Patient has a history of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty, colectomy or other surgery for Crohn's disease or ulcerative colitis; and
•Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or during Screening.

Locations (35)

Research Facility

Birmingham, Alabama, United States

Research Site

Chula Vista, California, United States

Research Site

Huntington Park, California, United States

Research Site

Lincoln, California, United States

Research Site

Los Angeles, California, United States

Research Site

Panorama City, California, United States

Research Site

San Diego, California, United States

Research Site

San Diego, California, United States

Research Site

Walnut Creek, California, United States

Research Site

Colorado Springs, Colorado, United States

Key Dates

Start Date

June 26, 2018

Primary Completion Date

July 2, 2019

Completion Date

July 2, 2019

Last Updated

July 8, 2019

Enrollment

557

ACTUAL participants

Conditions

Lactose Intolerance

Interventions

RP-G28

DRUG

Placebos

DRUG

Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers

NCT06177938

Lactose Intolerance

View study

RECRUITING

Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance

NCT06773650

Lactose IntolerantLactose Malabsorption+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

Inclusion Criteria

Exclusion Criteria

Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers

Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance

Effects of Raw Versus Other Milk Sources on Lactose Digestion

Effect of a Probiotic With High Beta-galactosidase Activity on Patients With Lactose Intolerance

The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)

Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption