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

Lactose Intolerance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597516
• Other study ID #: G28-006
• Status: Completed
• Phase: Phase 3
• Start date: June 26, 2018
• Est. completion date: July 2, 2019

Study information

• Verified date: July 2019
• Source: Ritter Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

Drug:
• RP-G28
powder for reconstitution for oral administration
• Placebos
powder for reconstitution for oral administration

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Bellevue	Washington
United States	Research Site	Berlin	New Jersey
United States	Research Facility	Birmingham	Alabama
United States	Research Site	Brooklyn	New York
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Dayton	Ohio
United States	Research Site	Fairfax	Virginia
United States	Research Site	Gainesville	Florida
United States	Research Site	Great Neck	New York
United States	Research Site	Hartsdale	New York
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Park	California
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lampasas	Texas
United States	Research Site	Lincoln	California
United States	Research Site	Los Angeles	California
United States	Research Site	Marrero	Louisiana
United States	Research Facility	Miami	Florida
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Oxon Hill	Maryland
United States	Research Site	Panorama City	California
United States	Reseaarch Site	Pompano Beach	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	San Antonio	Texas
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	Waxahachie	Texas
United States	Research Site	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ritter Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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