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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
LT-02
Placebo
Mesalamine
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

  • Signed informed consent
  • Men or women, 18 to 70 years of age
  • Historically confirmed diagnosis of UC by endoscopy and histology
  • Patients being in clinical and endoscopical remission at baseline
  • Negative pregnancy test in females of childbearing potential at baseline visit

Major Exclusion Criteria:

  • Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis
  • Toxic megacolon or fulminant colitis
  • Colon resection
  • Malabsorption syndromes
  • Celiac disease
  • Bleeding hemorrhoids
  • Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding
  • 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, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
  • Any relevant known systemic disease (e.g., AIDS, active tuberculosis)
  • Severe co-morbidity substantially reducing life expectancy
  • History of cancer in the last five years
  • Abnormal hepatic function at screening visit, liver cirrhosis
  • Abnormal renal function at screening visit
  • Patients with known hypersensitivity to soy
  • Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine)
  • Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization
  • Treatment with methotrexate within last 6 weeks prior to randomization
  • Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization
  • Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization
  • Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02
  • Existing or intended pregnancy or breast-feeding

Sites / Locations

  • Agaplesion Markus-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

LT-02

Placebo

Mesalamine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percentage of patients who are relapse-free and are not a treatment failure

Secondary Outcome Measures

Mean change from baseline in the total mDAI

Full Information

First Posted
October 29, 2014
Last Updated
January 23, 2020
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02280629
Brief Title
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
Acronym
PROTECT-2
Official Title
Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LT-02
Arm Type
Experimental
Arm Description
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
Arm Title
Mesalamine
Arm Type
Active Comparator
Arm Description
LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily
Intervention Type
Drug
Intervention Name(s)
LT-02
Intervention Description
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily
Primary Outcome Measure Information:
Title
Percentage of patients who are relapse-free and are not a treatment failure
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline in the total mDAI
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria: Signed informed consent Men or women, 18 to 70 years of age Historically confirmed diagnosis of UC by endoscopy and histology Patients being in clinical and endoscopical remission at baseline Negative pregnancy test in females of childbearing potential at baseline visit Major Exclusion Criteria: Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis Toxic megacolon or fulminant colitis Colon resection Malabsorption syndromes Celiac disease Bleeding hemorrhoids Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding 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, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results Any relevant known systemic disease (e.g., AIDS, active tuberculosis) Severe co-morbidity substantially reducing life expectancy History of cancer in the last five years Abnormal hepatic function at screening visit, liver cirrhosis Abnormal renal function at screening visit Patients with known hypersensitivity to soy Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine) Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization Treatment with methotrexate within last 6 weeks prior to randomization Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02 Existing or intended pregnancy or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Dignass, Prof Dr
Organizational Affiliation
Agaplesion Markus Krankenhaus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agaplesion Markus-Krankenhaus
City
Frankfurt a.M.
ZIP/Postal Code
60431
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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