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

Ritter Pharmaceuticals, Inc.3 sites in 1 country557 target enrollmentJune 26, 2018

ConditionsLactose Intolerance

InterventionsRP-G28 Placebos

DrugsRP-G28 Placebos

Overview

Phase: Phase 3
Intervention: RP-G28
Conditions: Lactose Intolerance
Sponsor: Ritter Pharmaceuticals, Inc.
Enrollment: 557
Locations: 3
Primary Endpoint: Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 26, 2018

End Date

July 2, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ritter Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

RP-G28

galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day

Intervention: RP-G28

Placebos

maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day

Intervention: Placebos

Outcomes

Primary Outcomes

Change from baseline of the Lactose Intolerance (LI) symptom composite score compared to placebo

Time Frame: Day 61

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.