NCT02142725

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 21, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2016

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

May 15, 2014

Last Update Submit

February 7, 2017

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical remission

    12 weeks

Secondary Outcomes (8)

  • Rate of patients with clinical improvement

    12 weeks

  • 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 mucosal healing

    12 weeks

  • +3 more secondary outcomes

Study Arms (3)

LT-02

EXPERIMENTAL

LT-02 0.8g four times daily

Drug: LT-02

B: LT-02

EXPERIMENTAL

LT-02 1.6g twice daily

Drug: LT-02

Placebo

PLACEBO COMPARATOR

LT-02 Placebo

Drug: Placebo

Interventions

LT-02DRUG

four times per day

LT-02
PlaceboDRUG

four times per day

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis of ulcerative colitis
  • Active ulcerative colitis disease extent ≥ 15 cm
  • Active disease despite treatment with mesalamine

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine

Frankfurt a.M., 60431, Germany

Location

Related Publications (1)

  • Dignass A, Stremmel W, Horynski M, Poyda O, Armerding P, Fellermann K, Langhorst J, Kuehbacher T, Uebel P, Stein J, Novacek G, Avalueva E, Oliinyk O, Hasselblatt P, Dorofeyev A, Heinemann H, Mueller R, Greinwald R, Reinisch W; International PROTECT-1/2 Study Groups. Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials. Clin Gastroenterol Hepatol. 2024 Apr;22(4):810-820.e7. doi: 10.1016/j.cgh.2023.09.031. Epub 2023 Oct 6.

    PMID: 37806372DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Axel Dignass, MD

    Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 20, 2014

Study Start

July 21, 2014

Primary Completion

November 11, 2016

Study Completion

December 16, 2016

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

DE(1)