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

Phase 1

Conditions: lcerative colitis
MedDRA version: 14.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2012-002023-15-AT

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the changes in molecular pathways of cell adhesion<br>(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<br>(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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Increase of the immune reactivity score of membranous E-cadherin in the normal<br>mucosa before and after 5-ASA treatment<br>- Change in the immune reactivity score of membranous ß-catenin in inflamed and<br>normal mucosa before and after 5-ASA treatment<br>- Changes in related chemopreventive pathways (Rac1/PAK-1, PI3K/Akt, ras/raf) prior to<br>and after treatment with 5-ASA<br>- Change in Mayo-Score (clinical and endoscopic ulcerative colitis activity score) from<br>baseline to study end;Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 +/- 2 days of treatment