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

Phase 3

Completed

• Conditions: Lactose Intolerance
• Interventions: Drug: Placebos; Drug: RP-G28

• Registration Number: NCT03597516
• Lead Sponsor: Ritter Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-26
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Status Verified: 2019-07
• Primary Completion: 2019-07-02
• Study Completion: 2019-07-02
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 557

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebos	Placebos	maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day
RP-G28	RP-G28	galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a meaningful reduction in LI composite score.	Day 61	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.

Trial Locations

Locations (3)

Research Site; 🇺🇸 Bellevue, Washington, United States

Reseaarch Site; 🇺🇸 Pompano Beach, Florida, United States

Research Facility; 🇺🇸 Miami, Florida, United States