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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RP-G28 | Experimental | galacto-oligosaccharide, spray-dried powder for reconstitution for oral administration, 7.5 grams 2 times per day |
|
| Placebos | Placebo Comparator | maltodextrin, powder for reconstitution for oral administration, 7.5 grams 2 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP-G28 | Drug | powder for reconstitution for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharron Gargosky, PhD | Ritter Pharmceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | Birmingham | Alabama | 35205 | United States | ||
| Research Site |
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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.
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| Placebos |
| Drug |
powder for reconstitution for oral administration |
|
| Chula Vista |
| California |
| 91910 |
| United States |
| Research Site | Huntington Park | California | 90255 | United States |
| Research Site | Lincoln | California | 95648 | United States |
| Research Site | Los Angeles | California | 90057 | United States |
| Research Site | Panorama City | California | 91402 | United States |
| Research Site | San Diego | California | 92114 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | Walnut Creek | California | 94598 | United States |
| Research Site | Colorado Springs | Colorado | 80906 | United States |
| Research Site | Gainesville | Florida | 32653 | United States |
| Research Facility | Miami | Florida | 33135 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Reseaarch Site | Pompano Beach | Florida | 33060 | United States |
| Research Site | Honolulu | Hawaii | 96815 | United States |
| Research Site | Marrero | Louisiana | 70072 | United States |
| Research Site | Oxon Hill | Maryland | 20745 | United States |
| Research Site | Wyoming | Michigan | 49519 | United States |
| Research Site | Omaha | Nebraska | 68114 | United States |
| Research Site | Berlin | New Jersey | 08009 | United States |
| Research Site | Albuquerque | New Mexico | 87102 | United States |
| Research Site | Brooklyn | New York | 11230 | United States |
| Research Site | Great Neck | New York | 11023 | United States |
| Research Site | Hartsdale | New York | 10530 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Cincinnati | Ohio | 45246 | United States |
| Research Site | Dayton | Ohio | 45439 | United States |
| Research Site | Charleston | South Carolina | 29406 | United States |
| Research Site | Knoxville | Tennessee | 37909 | United States |
| Research Site | Houston | Texas | 77099 | United States |
| Research Site | Lampasas | Texas | 76550 | United States |
| Research Site | San Antonio | Texas | 78209 | United States |
| Research Site | Waxahachie | Texas | 75165 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Bellevue | Washington | 98004 | United States |
| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000589718 | RP-G28 |
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