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

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.

Study Overview

• Status: Completed
• Conditions: Lactose Intolerance
• Intervention / Treatment: Drug: RP-G28; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 557
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Facility
  • California
    • Chula Vista, California, United States, 91910
      • Research Site
    • Huntington Park, California, United States, 90255
      • Research Site
    • Lincoln, California, United States, 95648
      • Research Site
    • Los Angeles, California, United States, 90057
      • Research Site
    • Panorama City, California, United States, 91402
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
    • San Diego, California, United States, 92114
      • Research Site
    • Walnut Creek, California, United States, 94598
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Research Site
  • Florida
    • Gainesville, Florida, United States, 32653
      • Research Site
    • Miami, Florida, United States, 33135
      • Research Facility
    • Orlando, Florida, United States, 32806
      • Research Site
    • Pompano Beach, Florida, United States, 33060
      • Reseaarch Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96815
      • Research Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Research Site
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • Research Site
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Research Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Research Site
  • New York
    • Brooklyn, New York, United States, 11230
      • Research Site
    • Great Neck, New York, United States, 11023
      • Research Site
    • Hartsdale, New York, United States, 10530
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Research Site
    • Dayton, Ohio, United States, 45439
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Research Site
  • Texas
    • Houston, Texas, United States, 77099
      • Research Site
    • Lampasas, Texas, United States, 76550
      • Research Site
    • San Antonio, Texas, United States, 78209
      • Research Site
    • Waxahachie, Texas, United States, 75165
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Research Site
  • Washington
    • Bellevue, Washington, United States, 98004
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RP-G28; galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day	Drug: RP-G28; powder for reconstitution for oral administration
PLACEBO_COMPARATOR: Placebos; maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day	Drug: Placebos; powder for reconstitution for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo	Change from baseline of the LI symptom composite score compared to placebo. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.	Day 61

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a meaningful reduction in LI composite score.	Proportion of patients with a meaningful reduction in LI composite score. The LI symptom composite score includes abdominal pain, abdominal bloating, abdominal cramping, and abdominal gas.	Day 61

Collaborators and Investigators

• Sponsor: Ritter Pharmaceuticals, Inc.
• Investigators: Study Director: Sharron Gargosky, PhD, Ritter Pharmceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2018
• Primary Completion (ACTUAL): July 2, 2019
• Study Completion (ACTUAL): July 2, 2019

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (ACTUAL): July 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Lactose Intolerance
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: G28-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No