Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance
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|ClinicalTrials.gov Identifier: NCT02673749|
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lactose Intolerance||Drug: RP-G28 Other: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||377 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
|Experimental: RP-G28 Dose 1||
Study drug taken orally
|Experimental: RP-G28 Dose 2||
Study drug taken orally
|Placebo Comparator: Placebo||
Placebo taken orally
- Change from baseline in abdominal pain [ Time Frame: Day 31 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673749
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|