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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 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.


Sponsor: Ritter Pharmaceuticals, Inc.

Current Primary Outcome: 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 ]

Original Primary Outcome: Change from Baseline in breath hydrogen production on Hydrogen Breath Test [ Time Frame: Baseline, 30 days ]

Current Secondary Outcome: Number of Subjects with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 36 days ]

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability


Original Secondary Outcome: Number of Subjects with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 30 days ]

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability


Information By: Ritter Pharmaceuticals, Inc.

Dates:
Date Received: April 23, 2010
Date Started: April 2011
Date Completion:
Last Updated: December 6, 2011
Last Verified: December 2011