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Trial record 12 of 32 for:    Open Studies | "Malabsorption Syndromes" | United States

Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Ritter Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Ritter Pharmaceuticals, Inc. Identifier:
First received: January 25, 2016
Last updated: February 1, 2016
Last verified: February 2016
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 Intervention Phase
Lactose Intolerance
Drug: RP-G28
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Ritter Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change from baseline in abdominal pain [ Time Frame: Day 31 ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 372
Study Start Date: February 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02673749

Contact: Julio C Juarez 310-203-1000

United States, New Jersey
Covance, Inc. Recruiting
Princeton, New Jersey, United States, 08540
Contact: Terri Sarno    303-466-3250   
Sponsors and Collaborators
Ritter Pharmaceuticals, Inc.
  More Information

Responsible Party: Ritter Pharmaceuticals, Inc. Identifier: NCT02673749     History of Changes
Other Study ID Numbers: G28-003 
Study First Received: January 25, 2016
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration

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:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases processed this record on October 25, 2016