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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03597516
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597516


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Locations
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United States, Alabama
Research Facility
Birmingham, Alabama, United States, 35205
United States, California
Research Site
Chula Vista, California, United States, 91910
Research Site
Huntington Park, California, United States, 90255
Research Site
Lincoln, California, United States, 95648
Research Site
Los Angeles, California, United States, 90057
Research Site
Panorama City, California, United States, 91402
Research Site
San Diego, California, United States, 92114
Research Site
San Diego, California, United States, 92123
Research Site
Walnut Creek, California, United States, 94598
United States, Colorado
Research Site
Colorado Springs, Colorado, United States, 80906
United States, Florida
Research Site
Gainesville, Florida, United States, 32653
Research Facility
Miami, Florida, United States, 33135
Research Site
Orlando, Florida, United States, 32806
Reseaarch Site
Pompano Beach, Florida, United States, 33060
United States, Hawaii
Research Site
Honolulu, Hawaii, United States, 96815
United States, Louisiana
Research Site
Marrero, Louisiana, United States, 70072
United States, Maryland
Research Site
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Research Site
Wyoming, Michigan, United States, 49519
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
Research Site
Berlin, New Jersey, United States, 08009
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Research Site
Brooklyn, New York, United States, 11230
Research Site
Great Neck, New York, United States, 11023
Research Site
Hartsdale, New York, United States, 10530
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45246
Research Site
Dayton, Ohio, United States, 45439
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29406
United States, Tennessee
Research Site
Knoxville, Tennessee, United States, 37909
United States, Texas
Research Site
Houston, Texas, United States, 77099
Research Site
Lampasas, Texas, United States, 76550
Research Site
San Antonio, Texas, United States, 78209
Research Site
Waxahachie, Texas, United States, 75165
United States, Virginia
Research Site
Fairfax, Virginia, United States, 22031
United States, Washington
Research Site
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Ritter Pharmaceuticals, Inc.
Investigators
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Study Director: Sharron Gargosky, PhD Ritter Pharmceuticals, Inc.

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Responsible Party: Ritter Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03597516     History of Changes
Other Study ID Numbers: G28-006
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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