Trial record 1 of 1 for:
NCT03597516
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance
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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 |
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Recruitment Status :
Completed
First Posted : July 24, 2018
Last Update Posted : July 8, 2019
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Sponsor:
Ritter Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Ritter Pharmaceuticals, Inc.
- Study Details
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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 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
Genetics Home Reference related topics:
Lactose intolerance
MedlinePlus related topics:
Lactose Intolerance
| Arm | Intervention/treatment |
|---|---|
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Experimental: RP-G28
galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day
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Drug: RP-G28
powder for reconstitution for oral administration |
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Placebo Comparator: Placebos
maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day
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Drug: Placebos
powder for reconstitution for oral administration |
Primary Outcome Measures :
- 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 :
- 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
Locations
| 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
| Study Director: | Sharron Gargosky, PhD | Ritter Pharmceuticals, Inc. |
| Responsible Party: | Ritter Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT03597516 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Ritter Pharmaceuticals, Inc.:
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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 |