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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
LT-02
LT-02
Placebo
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

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

Sites / Locations

  • Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LT-02

B: LT-02

Placebo

Arm Description

LT-02 0.8g four times daily

LT-02 1.6g twice daily

LT-02 Placebo

Outcomes

Primary Outcome Measures

Rate of clinical remission

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2014
Last Updated
February 7, 2017
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02142725
Brief Title
Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis
Acronym
PROTECT-1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
IDMC recommendation
Study Start Date
July 21, 2014 (Actual)
Primary Completion Date
November 11, 2016 (Actual)
Study Completion Date
December 16, 2016 (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 compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.

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
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LT-02
Arm Type
Experimental
Arm Description
LT-02 0.8g four times daily
Arm Title
B: LT-02
Arm Type
Experimental
Arm Description
LT-02 1.6g twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
LT-02 Placebo
Intervention Type
Drug
Intervention Name(s)
LT-02
Intervention Description
four times per day
Intervention Type
Drug
Intervention Name(s)
LT-02
Intervention Description
two times per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
four times per day
Primary Outcome Measure Information:
Title
Rate of clinical remission
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Rate of patients with clinical improvement
Time Frame
12 weeks
Title
Time to first resolution of symptoms
Time Frame
12 weeks
Title
Number of stools per week
Time Frame
12 weeks
Title
Number of days with urgency per week
Time Frame
12 weeks
Title
Rate of mucosal healing
Time Frame
12 weeks
Title
Rate of histologic remission
Time Frame
12 weeks
Title
Physician's global assessment at final visit
Time Frame
12 weeks
Title
Quality of life
Time Frame
12 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Dignass, MD
Organizational Affiliation
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
City
Frankfurt a.M.
ZIP/Postal Code
60431
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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