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

• ClinicalTrials.gov Identifier: NCT03597516
• Recruitment Status: Completed
• First Posted: July 24, 2018
• Last Update Posted: July 8, 2019
• Sponsor: Ritter Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Ritter Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lactose Intolerance	Drug: RP-G28; Drug: Placebos	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 557 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US). The study is comprised of 4 study periods.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: June 26, 2018
• Actual Primary Completion Date: July 2, 2019
• Actual Study Completion Date: July 2, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Proportion of patients with a meaningful reduction in LI composite score. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

  Show 35 Study Locations

Sponsors and Collaborators

Ritter Pharmaceuticals, Inc.

Investigators

• Study Director: Sharron Gargosky, PhD; Ritter Pharmceuticals, Inc.

More Information

• Responsible Party: Ritter Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03597516 History of Changes
• Other Study ID Numbers: G28-006
• First Posted: July 24, 2018
• Last Update Posted: July 8, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ritter Pharmaceuticals, Inc.:

Lactose Intolerance

Additional relevant MeSH terms:

Lactose Intolerance; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases