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

NCT ID: NCT01113619

Last Updated: 2011-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-12-31

Brief Summary

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

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.

Conditions

Lactose Intolerance

Keywords

lactose maldigestion; dairy intolerance; intolerance to milk; intolerance to dairy; milk intolerance; GI disorder; lactose metabolism; GI symptoms after dairy ingestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RP-G28

Study Drug RP-G28

Group Type: EXPERIMENTAL

RP-G28 or placebo

Intervention Type: DRUG

Qualified subjects randomized to daily dosing with RP-G28 or placebo

RP-G28 or placebo

Intervention Type: DRUG

Daily dosing

Placebo

Study Drug Placebo

Group Type: PLACEBO_COMPARATOR

RP-G28 or placebo

Intervention Type: DRUG

Qualified subjects randomized to daily dosing with RP-G28 or placebo

RP-G28 or placebo

Intervention Type: DRUG

Daily dosing

Interventions

RP-G28 or placebo

Qualified subjects randomized to daily dosing with RP-G28 or placebo

Intervention Type: DRUG

RP-G28 or placebo

Daily dosing

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ritter Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance, Inc. - Honolulu

Honolulu, Hawaii, United States

Covance, Inc. - Dallas

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24330605 (View on PubMed)

Other Identifiers

G28-001

Identifier Type: -

Identifier Source: org_study_id