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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-01

Study Completion Date

2018-10-05

Brief Summary

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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)

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LT-02

LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

Group Type EXPERIMENTAL

LT-02

Intervention Type DRUG

LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

Placebo

LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

Mesalamine

LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type DRUG

LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily

Interventions

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LT-02

LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

Intervention Type DRUG

Placebo

LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

Intervention Type DRUG

Mesalamine

LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No