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

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ClinicalTrials.gov Identifier: NCT02280629
Recruitment Status : Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

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)

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 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 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LT-02
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
Drug: LT-02
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

Placebo Comparator: Placebo
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
Drug: Placebo
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

Active Comparator: Mesalamine
LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily
Drug: Mesalamine
LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily




Primary Outcome Measures :
  1. Percentage of patients who are relapse-free and are not a treatment failure [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline in the total mDAI [ Time Frame: 48 weeks ]


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02280629


Locations
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Germany
Agaplesion Markus-Krankenhaus
Frankfurt a.M., Germany, 60431
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
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Principal Investigator: Axel Dignass, Prof Dr Agaplesion Markus Krankenhaus

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Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT02280629     History of Changes
Other Study ID Numbers: PCG-4/UCR
2013-001205-84 ( EudraCT Number )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents