A Phase 2/3 interventional study of RP-G28 and Placebo in Lactose Intolerance, sponsored by Ritter Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by Ritter Pharmaceuticals, Inc. · Phase 2/3, Interventional, and Treatment
RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products).
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.
Study Objective:
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.
Study Design:
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.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 377 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Ritter Pharmaceuticals, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion/Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: RP-G28
Drug: RP-G28
Other: Placebo
Study drug taken orally
Placebo taken orally
Change from baseline in abdominal pain
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.
Time frame: Day 31
The record gives a start of Feb 2016, a primary completion of Oct 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: RP-G28
Ritter Pharmaceuticals, Inc.