Trial | NCT01113619  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    61
This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.
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 Started
Apr 30
2011
Primary Completion
Oct 31
2011
Study Completion
Dec 31
2011
Last Update
Dec 08
2011
Estimate

Drug RP-G28 or placebo

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

Drug RP-G28 or placebo

Daily dosing

RP-G28 Experimental

Study Drug RP-G28

Placebo Placebo Comparator

Study Drug Placebo

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
No Results Posted