NCT03597516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
557

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 13, 2018

Last Update Submit

July 3, 2019

Conditions

Lactose Intolerance

Keywords

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Proportion of patients with a meaningful reduction in LI composite score.

    Day 61

Study Arms (2)

RP-G28

EXPERIMENTAL

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

Drug: RP-G28

Placebos

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

RP-G28DRUG

powder for reconstitution for oral administration

RP-G28
PlacebosDRUG

powder for reconstitution for oral administration

Placebos

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Research Facility

Birmingham, Alabama, 35205, United States

Location

Research Site

Chula Vista, California, 91910, United States

Location

Research Site

Huntington Park, California, 90255, United States

Location

Research Site

Lincoln, California, 95648, United States

Location

Research Site

Los Angeles, California, 90057, United States

Location

Research Site

Panorama City, California, 91402, United States

Location

Research Site

San Diego, California, 92114, United States

Location

Research Site

San Diego, California, 92123, United States

Location

Research Site

Walnut Creek, California, 94598, United States

Location

Research Site

Colorado Springs, Colorado, 80906, United States

Location

Research Site

Gainesville, Florida, 32653, United States

Location

Research Facility

Miami, Florida, 33135, United States

Location

Research Site

Orlando, Florida, 32806, United States

Location

Reseaarch Site

Pompano Beach, Florida, 33060, United States

Location

Research Site

Honolulu, Hawaii, 96815, United States

Location

Research Site

Marrero, Louisiana, 70072, United States

Location

Research Site

Oxon Hill, Maryland, 20745, United States

Location

Research Site

Wyoming, Michigan, 49519, United States

Location

Research Site

Omaha, Nebraska, 68114, United States

Location

Research Site

Berlin, New Jersey, 08009, United States

Location

Research Site

Albuquerque, New Mexico, 87102, United States

Location

Research Site

Brooklyn, New York, 11230, United States

Location

Research Site

Great Neck, New York, 11023, United States

Location

Research Site

Hartsdale, New York, 10530, United States

Location

Research Site

Raleigh, North Carolina, 27612, United States

Location

Research Site

Cincinnati, Ohio, 45246, United States

Location

Research Site

Dayton, Ohio, 45439, United States

Location

Research Site

Charleston, South Carolina, 29406, United States

Location

Research Site

Knoxville, Tennessee, 37909, United States

Location

Research Site

Houston, Texas, 77099, United States

Location

Research Site

Lampasas, Texas, 76550, United States

Location

Research Site

San Antonio, Texas, 78209, United States

Location

Research Site

Waxahachie, Texas, 75165, United States

Location

Research Site

Fairfax, Virginia, 22031, United States

Location

Research Site

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Lactose Intolerance

Interventions

RP-G28

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sharron Gargosky, PhD

    Ritter Pharmceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 24, 2018

Study Start

June 26, 2018

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(35)