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A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)

NCT02849951 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-06-15

No results posted yet for this study

Summary

The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine

Conditions

Interventions

DRUG

LT-02

12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)

DRUG

LT-02 Placebo

12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo

Sponsors & Collaborators

  • Nestlé Health Science Spain

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • Prometheus Laboratories

    lead INDUSTRY

Principal Investigators

  • Gregory Gordon, M.D., J.D. · Nestle Health Science, Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-03-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02849951 on ClinicalTrials.gov