Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment of symptomatic uncomplicated diverticular disease of colo

Phase 1

• Conditions: Treatment of symptomatic uncomplicated diverticular colon disease (SUDD); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 20.0Level: PTClassification code 10013538Term: DiverticulitisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2016-004159-56-IT
• Lead Sponsor: DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

1.In- or out-patients of both genders aged = 18 and = 75 years;
2.Patients with diverticular disease diagnosed by colonoscopy performed not before than 6 months before the enrolment in the study;
3.Patients with symptoms related to uncomplicated diverticular disease (i.e. abdominal pain, abdominal discomfort, bloating, flatulence) recurrent at least in the last six months;
Symptoms will be evaluated according to a structured questionnaire, based on a 5-point Likert scale, assessing frequency and based on a 10-point Likert scale, assessing severity. Patients will be considered eligible for the study when the abdominal pain total score (frequency plus severity) will be = 6 (independently of other gastrointestinal symptoms);
4.Written informed consent to participate in the study obtained according to GCP;
5.Patients able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator’s judgement;
6.Female subjects of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status – or not postmenopausal) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline.

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 410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 410

Exclusion Criteria

1.Patients with acute diverticulitis (both complicated and uncomplicated);
2.Patients with diverticular colitis;
3.Patients with solitary diverticulum of the colon;
4.Patients with active or recent peptic ulcer;
5.Patients with chronic liver, renal or hematologic diseases;
6.Patients with known allergy to salicylates;
7.Patients with previous major abdominal surgery;
8.Patients with concomitant colonic or extra colonic cancer or history of malignancy;
9.Patients with concomitant inflammatory bowel disease and celiac disease;
10.Use of antibiotics, probiotics and laxatives in the previous 4 weeks;
11.Use of non-steroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid in the last 4 weeks before study entry and throughout the overall study period. Acetylsalicylic acid and paracetamol may be taken in the last 4 weeks before study entry and throughout the overall study period;
12.Patients with intended or ascertained pregnancy, lactation or women of childbearing age not using contraceptives;
13.Patients with recent history or suspicion of alcohol abuse or drug addiction;
14.Patients unable to give a valid informed consent or to properly follow the protocol procedures;
15.Concomitant participation in another study or participation in the evaluation of any investigational drugs/devices during 3 months before this study or previous participation in the same investigation;
16.The participation in the investigation is also not permitted to employees of the investigational site with direct involvement in the study or in other studies under the direction of that Investigator, as well as family members of the employees or the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified