Mesapol: The effect of mesalazine on molecular pathways of cell adhesion in patients with colon polyps

Mesapol: The effect of mesalazine on molecular pathways of cell adhesion in patients with colon polyps - Mesapol

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002024-32-AT

Enrollment

Registered

2012-09-04

Start date

2012-09-21

Completion date

Unknown

Last updated

2018-09-10

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

Conditions

Colon polyps MedDRA version: 14.1 Level: LLT Classification code 10066021 Term: Acquired colon polyposis System Organ Class: 100000004856

Interventions

Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Current Sponsor code: 5-ASA Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients of at least 18 years of age that have consented to the study procedures and have signed the informed consent form - Patients who attend the clinic for screening colonoscopy - Patients who have an elevated polyp at least 1 cm in diameter located in the colon Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: - Inability to fully comprehend and/or to perform study procedures in the investigator’s opinion - Participation in any other interventional study within 1 month prior to screening - Complete polypectomy at initial colonoscopy - Known intolerance to 5-ASA (or its derivates) or other salicylates - Intake of 5-ASA (or its derivates), any NSAIDs or COX-2 inhibitors 10 days prior to screening - Concomitant medication with NSAIDs, COX-2 inhibitors, steroids, thiopurines, TNF-a antagonists, methotrexate, calcineurin inhibitors or mycophenolate - Presence of diverticulitis, inflammatory bowel disease or infectious colitis - Familial adenomatous polyposis, Lynch-syndrome or juvenile polyposis syndrome - Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the changes in molecular pathways of cell adhesion (E-cadherin and ß-catenin cellular localization) in colon polyps prior to and after treatment with mesalazine (5-ASA);Secondary Objective: To examine the changes in related chemopreventive pathways (Rac1/PAK-1, PI3K/Akt, ras/raf) in colon polyps prior to and after treatment with mesalazine;Primary end point(s): Increase of the immune reactivity score of membranous E-cadherin in epithelial cells of the polyps before and after mesalazine treatment;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 days of treatment	—

Measure

Time frame

Main Objective: To evaluate the changes in molecular pathways of cell adhesion (E-cadherin and ß-catenin cellular localization) in colon polyps prior to and after treatment with mesalazine (5-ASA);Secondary Objective: To examine the changes in related chemopreventive pathways (Rac1/PAK-1, PI3K/Akt, ras/raf) in colon polyps prior to and after treatment with mesalazine;Primary end point(s): Increase of the immune reactivity score of membranous E-cadherin in epithelial cells of the polyps before and after mesalazine treatment;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 days of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): - Increase of the immune reactivity score of membranous E-cadherin in the normal mucosa before and after mesalazine treatment - Change in the immune reactivity score of membranous ß-catenin in the polyps and in the normal mucosa before and after mesalazine treatment - Changes in related chemopreventive pathways (Rac1/PAK-1, PI3K/Akt, ras/raf) in the polyps and in the normal mucosa prior to and after treatment with mesalazine ;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 days of treatment	—

Measure

Time frame

Secondary end point(s): - Increase of the immune reactivity score of membranous E-cadherin in the normal mucosa before and after mesalazine treatment - Change in the immune reactivity score of membranous ß-catenin in the polyps and in the normal mucosa before and after mesalazine treatment - Changes in related chemopreventive pathways (Rac1/PAK-1, PI3K/Akt, ras/raf) in the polyps and in the normal mucosa prior to and after treatment with mesalazine ;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 days of treatment

—

Countries

Austria

Contacts

Public ContactMedical University of Vienna

Dept. of Medicine 3, Div. of Gastroenterology, Christian Doppler Laboratory for Molecular Cancer Chemoprevention, MUV

christoph.gasche@meduniwien.ac.at00431404004764

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026