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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02142725
Recruitment Status : Terminated (IDMC recommendation)
First Posted : May 20, 2014
Last Update Posted : February 9, 2017
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: LT-02 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 21, 2014
Actual Primary Completion Date : November 11, 2016
Actual Study Completion Date : December 16, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LT-02
LT-02 0.8g four times daily
Drug: LT-02
four times per day

Experimental: B: LT-02
LT-02 1.6g twice daily
Drug: LT-02
two times per day

Placebo Comparator: Placebo
LT-02 Placebo
Drug: Placebo
four times per day

Primary Outcome Measures :
  1. Rate of clinical remission [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Rate of patients with clinical improvement [ Time Frame: 12 weeks ]
  2. Time to first resolution of symptoms [ Time Frame: 12 weeks ]
  3. Number of stools per week [ Time Frame: 12 weeks ]
  4. Number of days with urgency per week [ Time Frame: 12 weeks ]
  5. Rate of mucosal healing [ Time Frame: 12 weeks ]
  6. Rate of histologic remission [ Time Frame: 12 weeks ]
  7. Physician's global assessment at final visit [ Time Frame: 12 weeks ]
  8. Quality of life [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02142725

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Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Frankfurt a.M., Germany, 60431
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Principal Investigator: Axel Dignass, MD Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT02142725    
Other Study ID Numbers: PCG-2/UCA
2012-003702-27 ( EudraCT Number )
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases