Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis (PROTECT-1)

February 7, 2017 updated by: Dr. Falk Pharma GmbH

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

468

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt a.M., Germany, 60431
        • Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Established diagnosis of ulcerative colitis
  • Active ulcerative colitis disease extent ≥ 15 cm
  • Active disease despite treatment with mesalamine

Exclusion Criteria:

  • Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
  • Toxic megacolon or fulminant colitis
  • Colon resection
  • Evidence of infectious colitis
  • Celiac disease
  • Bleeding hemorrhoids
  • History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
  • Any severe concomitant renal, endocrine, or psychiatric disorder
  • Any relevant known systemic disease
  • History of cancer in the last five years
  • Abnormal hepatic function or liver cirrhosis
  • Abnormal HbA1c at screening visit
  • Patients with known hypersensitivity to soy
  • Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
  • Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
  • Treatment with other investigational drug
  • Existing or intended pregnancy or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LT-02
LT-02 0.8g four times daily
Drug: LT-02
four times per day
Drug: LT-02
two times per day
Experimental: B: LT-02
LT-02 1.6g twice daily
Drug: LT-02
four times per day
Drug: LT-02
two times per day
Placebo Comparator: Placebo
LT-02 Placebo
Drug: Placebo
four times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of clinical remission
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 12 weeks
12 weeks
Rate of patients with clinical improvement
Time Frame: 12 weeks
12 weeks
Time to first resolution of symptoms
Time Frame: 12 weeks
12 weeks
Number of stools per week
Time Frame: 12 weeks
12 weeks
Number of days with urgency per week
Time Frame: 12 weeks
12 weeks
Rate of mucosal healing
Time Frame: 12 weeks
12 weeks
Rate of histologic remission
Time Frame: 12 weeks
12 weeks
Physician's global assessment at final visit
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Axel Dignass, MD, Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2014

Primary Completion (Actual)

November 11, 2016

Study Completion (Actual)

December 16, 2016

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCG-2/UCA
  • 2012-003702-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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