Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effectiveness, Safety and Tolerability of RP-G28 in Subjects With Symptoms Associated With Lactose Intolerance

This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.

Study Overview

• Status: Completed
• Conditions: Lactose Intolerance
• Intervention / Treatment: Drug: RP-G28 or placebo; Drug: RP-G28 or placebo

Detailed Description

Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming too much 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/cramps, 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.

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. This study will evaluate a treatment that provides a simplified dosing regimen as well as the potential for extended relief from symptoms following a limited therapy regimen.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Covance, Inc. - Honolulu
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance, Inc. - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects. Female subjects must be non-pregnant and non-lactating.
• 18 to 64 years of age inclusive at Screening
• Current or recent history of intolerance to milk and other dairy products
• Acceptable Baseline Lactose Intolerance Symptom Scores
• Acceptable Result on Baseline Hydrogen Breath Test
• Subjects must agree to refrain from all other treatments and products used for lactose intolerance during the study

Exclusion Criteria:

• Disorders known to be associated with abnormal GI motility
• History of surgery that alters the normal function of the gastrointestinal tract
• Past or present; organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS)
• Active gastric or duodenal ulcers or history of severe ulcers
• Diabetes mellitus (type 1 or type 2)
• Congestive Heart Failure
• History of Human Immunodeficiency Virus (HIV), Hepatitis B or C
• Use of concurrent therapy(ies) for symptoms of lactose intolerance
• Uncontrolled BP defined as sitting systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥95 mmHg at Visit 1
• History of ethanol abuse in the past 12 months
• History of drug abuse within 12 months
• History or presence of malignancy within the past 5 years (except basal cell or squamous cell carcinoma removed from a sun-exposed area)
• Use of any investigational drug or participation in any investigational study within 30 days prior to Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RP-G28; Study Drug RP-G28	Drug: RP-G28 or placebo; Qualified subjects randomized to daily dosing with RP-G28 or placebo; Drug: RP-G28 or placebo; Daily dosing
Placebo Comparator: Placebo; Study Drug Placebo	Drug: RP-G28 or placebo; Qualified subjects randomized to daily dosing with RP-G28 or placebo; Drug: RP-G28 or placebo; Daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge	Baseline, 36 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with Adverse Events as Measure of Safety and Tolerability	Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	36 days

Collaborators and Investigators

• Sponsor: Ritter Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Savaiano DA, Ritter AJ, Klaenhammer TR, James GM, Longcore AT, Chandler JR, Walker WA, Foyt HL. Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial. Nutr J. 2013 Dec 13;12:160. doi: 10.1186/1475-2891-12-160.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: GI disorder; GI symptoms after dairy ingestion; lactose maldigestion; dairy intolerance; intolerance to milk; intolerance to dairy; milk intolerance; lactose metabolism
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: G28-001