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

Completed · Phase 3 · Has a placebo group

Conditions studied: Lactose Intolerance

In brief

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.

Key facts

Study ID: NCT03597516
Run by: Ritter Pharmaceuticals, Inc.
People needed: 557
Starts: 2018-06-26
Expected to finish: 2019-07-02
Last updated by the study team: 2019-07-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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
Research Site — Gainesville, Florida, United States
Research Facility — Miami, Florida, United States
Research Site — Orlando, Florida, United States
Reseaarch Site — Pompano Beach, Florida, United States
Research Site — Honolulu, Hawaii, United States
Research Site — Marrero, Louisiana, United States
Research Site — Oxon Hill, Maryland, United States
Research Site — Wyoming, Michigan, United States
Research Site — Omaha, Nebraska, United States
Research Site — Berlin, New Jersey, United States
Research Site — Albuquerque, New Mexico, United States
Research Site — Brooklyn, New York, United States
Research Site — Great Neck, New York, United States
Research Site — Hartsdale, New York, United States
Research Site — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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