NCT02280629

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

October 29, 2014

Last Update Submit

January 23, 2020

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who are relapse-free and are not a treatment failure

    48 weeks

Secondary Outcomes (1)

  • Mean change from baseline in the total mDAI

    48 weeks

Study Arms (3)

LT-02

EXPERIMENTAL

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

Drug: LT-02

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Mesalamine

ACTIVE COMPARATOR

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

Drug: Mesalamine

Interventions

LT-02DRUG

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

LT-02
PlaceboDRUG

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

Placebo
MesalamineDRUG

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

Mesalamine

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agaplesion Markus-Krankenhaus

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

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Axel Dignass, Prof Dr

    Agaplesion Markus Krankenhaus

    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

October 29, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

October 5, 2018

Study Completion

October 5, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

DE(1)