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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lactose Intolerance

In brief

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

Key facts

Study ID

NCT01113619

Run by

Ritter Pharmaceuticals, Inc.

People needed

61

Starts

2011-04-01

Expected to finish

2011-12-01

Last updated by the study team

2011-12-08

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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