Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance
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
1 other identifier
interventional
377
1 country
1
Brief Summary
RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedApril 4, 2018
April 1, 2017
8 months
January 25, 2016
April 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 31
Study Arms (3)
RP-G28 Dose 1
EXPERIMENTALRP-G28 Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- Female subjects must be non pregnant, and non lactating. Females of childbearing potential must use adequate birth control during study participation
- Medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance.
- Must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), Celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (SIBO), active gastric or duodenal ulcers, or history of severe ulcers.
- Must be nicotine free.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance, Inc.
Princeton, New Jersey, 08540, United States
Related Publications (1)
Azcarate-Peril MA, Roach J, Marsh A, Chey WD, Sandborn WJ, Ritter AJ, Savaiano DA, Klaenhammer TR. A double-blind, 377-subject randomized study identifies Ruminococcus, Coprococcus, Christensenella, and Collinsella as long-term potential key players in the modulation of the gut microbiome of lactose intolerant individuals by galacto-oligosaccharides. Gut Microbes. 2021 Jan-Dec;13(1):1957536. doi: 10.1080/19490976.2021.1957536.
PMID: 34365905DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2016
First Posted
February 4, 2016
Study Start
February 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
April 4, 2018
Record last verified: 2017-04