NCT01113619 is a Phase 2 clinical trial of RP-G28 or placebo in Lactose Intolerance, sponsored by Ritter Pharmaceuticals, Inc..

Who is sponsoring NCT01113619?

NCT01113619 is sponsored by Ritter Pharmaceuticals, Inc..

What drugs are being tested in NCT01113619?

Interventions in NCT01113619: RP-G28 or placebo, RP-G28 or placebo.

What condition does NCT01113619 study?

NCT01113619 studies Lactose Intolerance.

Is NCT01113619 still recruiting?

NCT01113619 is currently completed. Last updated 6 December 2011.

Last reviewed 2011-12-06 · How we verify

NCT01113619

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effectiveness, Safety and Tolerability of RP-G28 in Subjects With Symptoms Associated With Lactose Intolerance

Completed Phase 2 Last updated 6 December 2011

What this trial tests

Phase 2 trial testing RP-G28 or placebo in Lactose Intolerance in 61 participants. Completed in 1 December 2011.

Timeline

1 April 2011

Primary endpoint
1 October 2011

1 December 2011

Quick facts

Lead sponsor	Ritter Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	61
Start date	1 April 2011
Primary completion	1 October 2011
Estimated completion	1 December 2011
Sites	2 locations across United States

Drugs / interventions tested

RP-G28 or placebo — full drug profile →
RP-G28 or placebo — full drug profile →

Conditions studied

Lactose Intolerance — all drugs for Lactose Intolerance →

Sponsor

Ritter Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 64, any sex, with Lactose Intolerance. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge
Time frame: Baseline, 36 days

Sponsor's own description

This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial.
Savaiano DA, Ritter AJ, Klaenhammer TR, James GM, et al · · 2013 · cited 55× · PMID 24330605 · DOI 10.1186/1475-2891-12-160

Verify or expand the search:

Other Ritter Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03597516 — Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance · Phase 3 · completed
NCT03563846 — Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01113619 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ritter Pharmaceuticals, Inc.
Last refreshed: 6 December 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01113619.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing