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Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

NCT02280629 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-01-27

No results posted yet for this study

Summary

The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)

Conditions

Interventions

DRUG

LT-02

LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

DRUG

Placebo

LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

DRUG

Mesalamine

LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Axel Dignass, Prof Dr · Agaplesion Markus Krankenhaus

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
2014-10-01
Primary Completion
2018-10-05
Completion
2018-10-05

Countries

  • Germany

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Entities

Drugs
Diseases

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 NCT02280629 on ClinicalTrials.gov