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

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ClinicalTrials.gov Identifier: NCT02142725
Recruitment Status : Terminated (IDMC recommendation)
First Posted : May 20, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

May 15, 2014
May 20, 2014
February 9, 2017
July 21, 2014
November 11, 2016   (Final data collection date for primary outcome measure)
Rate of clinical remission [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT02142725 on ClinicalTrials.gov Archive Site
  • Rate of patients with clinical improvement [ Time Frame: 12 weeks ]
  • Time to first resolution of symptoms [ Time Frame: 12 weeks ]
  • Number of stools per week [ Time Frame: 12 weeks ]
  • Number of days with urgency per week [ Time Frame: 12 weeks ]
  • Rate of mucosal healing [ Time Frame: 12 weeks ]
  • Rate of histologic remission [ Time Frame: 12 weeks ]
  • Physician's global assessment at final visit [ Time Frame: 12 weeks ]
  • Quality of life [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: LT-02
    four times per day
  • Drug: LT-02
    two times per day
  • Drug: Placebo
    four times per day
  • Experimental: LT-02
    LT-02 0.8g four times daily
    Intervention: Drug: LT-02
  • Experimental: B: LT-02
    LT-02 1.6g twice daily
    Intervention: Drug: LT-02
  • Placebo Comparator: Placebo
    LT-02 Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
468
762
December 16, 2016
November 11, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02142725
PCG-2/UCA
2012-003702-27 ( EudraCT Number )
Yes
Not Provided
Not Provided
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Principal Investigator: Axel Dignass, MD Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Dr. Falk Pharma GmbH
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP