E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023003 |
E.1.2 | Term | Irritable bowel syndrome |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 therapeutic role of oral SCG on the symptoms of patients with Inflammatory Bowel Syndrome (IBS) with incresed number of activated mastcells (MC) in the colon lamina propria. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the variations in the severity and frequency of the symptoms during the study in the two treatment groups ( as referred to the histological and immunochemical appearance of the colic mucosa before treatment). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Age >18 years and < 80 years 2- Positive diagnosis for IBS, established in conformity to ROMA II criteria on the basis of presence of pain or discomfort for at least 12 weeks in the last year with at least two of the following characteristics: a) attenuated stools and b) associated initially with variation in the stool frequency; c) associated initially with stool consistency variations. 3- Lack of predominant symptoms of dyspepsia and/or GERD. 4-If female, should be infertile ( post menopause or because of surgery) or, if fertile, requested to use a valid contraceptive system and undergo to the pregnancy test that must give negative response at the time of enrolment. 5- If female, must not be breastfeeding 6- Good general health on the basis of the anamnesis, objective examination, laboratory tests. Subjects with food intolerance or bacterial contamination of the intestine not adequately responsive to therapy. 7- Rectal sigmoidoscopy with two biopsies of the colic mucosa of the descending colon. 8- Patients’ written informed consent, approved by the local Ethic Committee before the start of any study procedure.
|
|
E.4 | Principal exclusion criteria |
Patients wil be excluded from the study on the basis of the following conditions: 1- Abdominal surgery ( exception made for hysterectomy, caesarean appendicectomy, colecistectomy, plastic surgery for inguinal hernia. 2- Recent history ( previous six months ) of drug and alcohol abuse. 3- Recent intake ( previous 4 months) of test medication. 4- Concomitant use of medications that influence gastrointestinal functions ( anti-cholinergic, spasmolytics, pro-kinetics, anti-diarrhoeal, opium derivatives, laxatives), as well as antidepressant and serotonin agonists and antagonists. 5- Presence of cardiac, renal, neurological, psychiatric, neoplastic, endocrine, methabolic diseases. 6- Proven or suspected neoplastic pathology with the exception of basal carcinoma or skin squamous cells type , adequately treated.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point of the study is the evaluation of the number of responders among patients with an increased number of MC ( > 4.8% of the area of histological field populated with MCs) of the lamina propria in the two treatment groups. A responder is defined by its adequate amelioration of symptoms due to IBS in at least 50% of the evaluations in the course 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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 33 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 33 |
E.8.9.2 | In all countries concerned by the trial days | 0 |