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

Dr. Falk Pharma

Status and phase: Terminated; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: LT-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT02142725

PCG-2/UCA

2012-003702-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 468 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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468 participants in 3 patient groups, including a placebo group

LT-02

Experimental group

Description:

LT-02 0.8g four times daily

Treatment:

Drug: LT-02

Drug: LT-02

B: LT-02

Experimental group

Description:

LT-02 1.6g twice daily

Treatment:

Drug: LT-02

Drug: LT-02

Placebo

Placebo Comparator group

Description:

LT-02 Placebo

Treatment:

Drug: Placebo