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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 September 2018 |
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Main ID: |
EUCTR2012-002023-15-AT |
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Date of registration:
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04/09/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Mesacol: The effect of mesalazine on molecular pathways of
cell adhesion in ulcerative colitis
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Scientific title:
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Mesacol: The effect of mesalazine on molecular pathways of
cell adhesion in ulcerative colitis - Mesacol |
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Date of first enrolment:
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21/09/2012 |
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Target sample size:
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12 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002023-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Contacts
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Name:
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Medizinische Universität Wien
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Address:
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Währinger Gürtel 18-20
1090
Wien
Austria |
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Telephone:
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00431404004764 |
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Email:
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christoph.gasche@meduniwien.ac.at |
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Affiliation:
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Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie |
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Name:
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Medizinische Universität Wien
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Address:
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Währinger Gürtel 18-20
1090
Wien
Austria |
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Telephone:
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00431404004764 |
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Email:
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christoph.gasche@meduniwien.ac.at |
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Affiliation:
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Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Ulcerative colitis
MedDRA version: 14.1
Level: LLT
Classification code 10045366
Term: Ulcerative colitis, unspecified
System Organ Class: 100000004856
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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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 descriptive name: 5-aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1200-
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Primary Outcome(s)
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Primary end point(s): Increase of the immune reactivity score of membranous E-cadherin in the inflamed mucosa before and after 5-ASA treatment
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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)
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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
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Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 +/- 2 days of treatment
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Prior to treatment and after 14 +/- 2 days of treatment
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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
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Source(s) of Monetary Support
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Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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