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

Ritter Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Lactose Intolerance

Treatments

Drug: RP-G28 or placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01113619

G28-001

Details and patient eligibility

About

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

Full 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.

Enrollment

61 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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