Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Two Doses of RP-G28 in Subjects With Lactose Intolerance|
- Change from baseline in abdominal pain [ Time Frame: Day 31 ] [ Designated as safety issue: No ]Percent change from baseline to Day 31 of AUC abdominal pain symptom score based on measures taken after a lactose challenge test at 1, 2, 3, 4, and 5 hours. The method of assessment for this outcome measure is an 11-point numeric rating scale completed by the subject.
|Study Start Date:||February 2016|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
|Experimental: RP-G28 Dose 1||
Study drug taken orally
|Experimental: RP-G28 Dose 2||
Study drug taken orally
|Placebo Comparator: Placebo||
Placebo taken orally
Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming 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, cramping, 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. Currently, there are no approved treatments for this condition.
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.
To access efficacy of two RP-G28 dosing regimes on symptoms related to lactose intolerance relative to placebo after 30 days of treatment. The 30 day post-treatment phase will further evaluate the treatment's potential to prolong relief from symptoms.
The participants will take about 60 days to complete the study. The study consists of 3 distinct phases: Screening, a 30-day Treatment Phase, and a 30-day Post-Treatment Phase (off study treatment observation period). A participant will need to visit the clinical only 6 times throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02673749
|Contact: Julio C Juarez||310-203-1000||Julio@ritterpharma.com|
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Contact: Terri Sarno 303-466-3250 Terri.Sarno@Covance.com|