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Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects 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: NCT02673749
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ritter Pharmaceuticals, Inc.

Brief Summary:
RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products).

Condition or disease Intervention/treatment Phase
Lactose Intolerance Drug: RP-G28 Other: Placebo Phase 2 Phase 3

Detailed Description:

Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming lactose or when lactose is added to a previously low-lactose diet. Lactose intolerance is characterized by one or more of the cardinal symptoms that follow the ingestion of lactose-containing foods. These symptoms include; abdominal pain, cramping, bloating, flatulence [gas] and diarrhea. As such, most lactose intolerant individuals avoid the ingestion of milk and dairy products, while others substitute non-lactose containing products in their diet. Currently, there are no approved treatments for this condition.

Based on the health implications from insufficient calcium intake over a lifetime, including increased risk of osteoporosis and hypertension, there is need in the medical community for a tolerable and convenient treatment that allows for all levels of milk and dairy product consumption in people suffering from mild to severe lactose intolerance.

Study Objective:

To access efficacy of two RP-G28 dosing regimes on symptoms related to lactose intolerance relative to placebo after 30 days of treatment. The 30 day post-treatment phase will further evaluate the treatment's potential to prolong relief from symptoms.

Study Design:

The participants will take about 60 days to complete the study. The study consists of 3 distinct phases: Screening, a 30-day Treatment Phase, and a 30-day Post-Treatment Phase (off study treatment observation period). A participant will need to visit the clinical only 6 times throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Two Doses of RP-G28 in Subjects With Lactose Intolerance
Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RP-G28 Dose 1 Drug: RP-G28
Study drug taken orally

Experimental: RP-G28 Dose 2 Drug: RP-G28
Study drug taken orally

Placebo Comparator: Placebo Other: Placebo
Placebo taken orally




Primary Outcome Measures :
  1. Change from baseline in abdominal pain [ Time Frame: Day 31 ]
    Percent change from baseline to Day 31 of AUC abdominal pain symptom score based on measures taken after a lactose challenge test at 1, 2, 3, 4, and 5 hours. The method of assessment for this outcome measure is an 11-point numeric rating scale completed by the subject.



Information from the National Library of Medicine

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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/Exclusion Criteria:

  • Female subjects must be non pregnant, and non lactating. Females of childbearing potential must use adequate birth control during study participation
  • Medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance.
  • Must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), Celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (SIBO), active gastric or duodenal ulcers, or history of severe ulcers.
  • Must be nicotine free.

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): NCT02673749


Locations
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United States, New Jersey
Covance, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Ritter Pharmaceuticals, Inc.

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Responsible Party: Ritter Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02673749    
Other Study ID Numbers: G28-003
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2017
Keywords provided by Ritter Pharmaceuticals, Inc.:
Lactose maldigestion
Dairy intolerance
Intolerance to milk
Intolerance to dairy
Milk intolerance
GI disorder
Lactose metabolism
GI symptoms after dairy ingestion
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