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

This study has been terminated.
(IDMC recommendation)
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT02142725
First received: May 15, 2014
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Ulcerative Colitis Drug: LT-02 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 468
Actual Study Start Date: July 21, 2014
Study Completion Date: December 16, 2016
Primary Completion Date: November 11, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02142725

Locations
Germany
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Frankfurt a.M., Germany, 60431
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Axel Dignass, MD Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
  More Information

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT02142725     History of Changes
Other Study ID Numbers: PCG-2/UCA
2012-003702-27 ( EudraCT Number )
Study First Received: May 15, 2014
Last Updated: February 7, 2017

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on September 25, 2017