E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative colitis |
Colitis ulcerosa |
|
E.1.1.1 | Medical condition in easily understood language |
Ulcerative colitis |
Colitis ulcerosa |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045366 |
E.1.2 | Term | Ulcerative colitis, unspecified |
E.1.2 | System Organ Class | 100000004856 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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-α antagonists, methotrexate, calcineurin inhibitors or mycophenolate. - The presence of infectious colitis - Pregnancy or lactation |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Increase of the immune reactivity score of membranous E-cadherin in the inflamed mucosa before and after 5-ASA treatment |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Prior to treatment and after 14 +/- 2 days of treatment |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Prior to treatment and after 14 +/- 2 days of treatment |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Basic scientific study on human material (molecular mechanisms of drug action) |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject is the end of the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |