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Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

NCT03597516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2019-07-08

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.

Conditions

  • Lactose Intolerance

Interventions

DRUG

RP-G28

powder for reconstitution for oral administration

DRUG

Placebos

powder for reconstitution for oral administration

Sponsors & Collaborators

  • Ritter Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharron Gargosky, PhD · Ritter Pharmceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2019-07-02
Completion
2019-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597516 on ClinicalTrials.gov