Mesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitis

Mesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitis - Mesacol

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002023-15-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

Ulcerative colitis MedDRA version: 14.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified 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 with mild to moderate ulcerative colitis (as defined by the Truelove and Witts criteria) who have not received 5-ASA derivates or other salicylates for the past 10 days 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 - 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. - The presence of infectious colitis - Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the changes in molecular pathways of cell adhesion (cellular localization of E-cadherin and ß-catenin) in ulcerative colitis 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 ulcerative colitis prior to and after treatment with mesalazine;Primary end point(s): Increase of the immune reactivity score of membranous E-cadherin in the inflamed mucosa before and after 5-ASA treatment;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 +/- 2 days of treatment	—

Measure

Time frame

Main Objective: To evaluate the changes in molecular pathways of cell adhesion (cellular localization of E-cadherin and ß-catenin) in ulcerative colitis 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 ulcerative colitis prior to and after treatment with mesalazine;Primary end point(s): Increase of the immune reactivity score of membranous E-cadherin in the inflamed mucosa before and after 5-ASA treatment;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 +/- 2 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 5-ASA treatment - Change in the immune reactivity score of membranous ß-catenin in inflamed and normal mucosa before and after 5-ASA treatment - Changes in related chemopreventive pathways (Rac1/PAK-1, PI3K/Akt, ras/raf) prior to and after treatment with 5-ASA - Change in Mayo-Score (clinical and endoscopic ulcerative colitis activity score) from baseline to study end;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 +/- 2 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 5-ASA treatment - Change in the immune reactivity score of membranous ß-catenin in inflamed and normal mucosa before and after 5-ASA treatment - Changes in related chemopreventive pathways (Rac1/PAK-1, PI3K/Akt, ras/raf) prior to and after treatment with 5-ASA - Change in Mayo-Score (clinical and endoscopic ulcerative colitis activity score) from baseline to study end;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 +/- 2 days of treatment

—

Countries

Austria

Contacts

Public ContactMedizinische Universität Wien

Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie

christoph.gasche@meduniwien.ac.at00431404004764

Outcome results

None listed

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