EFFICACY OF ORAL SODIUM CROMOGLICATE IN PATIENTS WITH IRRITABLE BOWELSYNDROME: A MULTI-CENTRE, RANDOMIZED, GROUP COMPARATIVE, DOUBLE -BLIND,PLACEBO CONTROLLED STUDY

Phase 1

• Conditions: IRRITABLE BOWEL SYNDROME; MedDRA version: 12.0Level: LLTClassification code 10023003Term: Irritable bowel syndrome

• Registration Number: EUCTR2005-003625-46-CZ
• Lead Sponsor: Italchimici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-17
• Study Completion: 2012-12-01
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

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 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.;Secondary Objective: 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).;Primary end point(s): The primary end-point of the study is the evaluation of the number of responders among patients with an<br>increased number of MC ( > 4.8% of the area of histological field populated with MCs) of the lamina propria in<br>the two treatment groups. A responder is defined by its adequate amelioration of symptoms due to IBS in at least<br>50% of the evaluations in the course of treatment.