Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intol… (NCT01113619) | Clinical Trial Compass
CompletedPhase 2
Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
United States61 participantsStarted 2011-04
Plain-language summary
This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 investig…
What they're measuring
1
1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge