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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02142725

Acronym

PROTECT-1

Enrollment

468

Registered

2014-05-20

Start date

2014-07-21

Completion date

2016-12-16

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

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.

Interventions

DRUGLT-02

four times per day

DRUGPlacebo

four times per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Rate of clinical remission	12 weeks

Secondary

Measure	Time frame
Time to first resolution of symptoms	12 weeks
Number of stools per week	12 weeks
Number of days with urgency per week	12 weeks
Rate of patients with clinical improvement	12 weeks
Rate of histologic remission	12 weeks
Physician's global assessment at final visit	12 weeks
Quality of life	12 weeks
Rate of mucosal healing	12 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026