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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
Qualified subjects randomized to daily dosing with RP-G28 or placebo
Daily dosing
Covance, Inc. - Honolulu
Honolulu, Hawaii, United States
Covance, Inc. - Dallas
Dallas, Texas, United States
1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge
Time frame: Baseline, 36 days
Number of Subjects with Adverse Events as Measure of Safety and Tolerability
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time frame: 36 days
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