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

Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment of symptomatic uncomplicated diverticular disease of colon: multi-centre, randomised, double-blind, double - dummy, parallel group, placebo-controlled study (MERISUDD study) - Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004159-56-IT

Enrollment

820

Registered

2021-05-25

Start date

2017-10-12

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of symptomatic uncomplicated diverticular colon disease (SUDD) MedDRA version: 20.0 Level: PT Classification code 10013538 Term: Diverticulitis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: NORMIX - 200 MG COMPRESSE RIVESTITE CON FILM 12 COMPRESSE Product Name: Rifaximina Product Code: Rifaximina Pharmaceutical Form: Tablet INN or Proposed INN: RIFAXIMINA CAS Number: 80621-81

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate the efficacy of non-absorbable antibiotics (i.e. rifaximin) and/or anti-inflammatory drugs (i.e. mesalazine) in the prevention of diverticulitis in patients with symptomatic uncomplicated diverticular disease of the colon;Secondary Objective: To evaluate the efficacy of rifaximin and/or mesalazine on symptoms 'relief and quality of life in patients with symptomatic uncomplicated diverticular disease of the colon; To address the risk / benefit and cost / benefit profile of rifaximin and/or mesalazine treatment of patients in the long-term treatment of patients with symptomatic uncomplicated diverticular disease of the colon;Primary end point(s): • Rate of patients with episodes of acute diverticulitis and/or complications. An episode of diverticulitis will be defined based on: a) Signs and symptoms (i.e. pain, fever, abdominal tenderness); b) Laboratory tests: erythro-sedimentation rate (ESR), high-specificity C-reactive protein (hs-CRP), increase in white blood cells (WBCs) count; c) Abdominal computerised tomography (CT). ;Timepoint(s) of evaluation of this end point: Extra-visits can be arranged at any time during the study on patient’s request in case of signs and symptoms suggestive of acute diverticulitis and/or complications, in which the investigator will perform further physical examination, laboratory and TC to confirm or exclude this diagnosis (primary variable).	—

Measure

Time frame

Main Objective: The primary objective is to evaluate the efficacy of non-absorbable antibiotics (i.e. rifaximin) and/or anti-inflammatory drugs (i.e. mesalazine) in the prevention of diverticulitis in patients with symptomatic uncomplicated diverticular disease of the colon;Secondary Objective: To evaluate the efficacy of rifaximin and/or mesalazine on symptoms 'relief and quality of life in patients with symptomatic uncomplicated diverticular disease of the colon; To address the risk / benefit and cost / benefit profile of rifaximin and/or mesalazine treatment of patients in the long-term treatment of patients with symptomatic uncomplicated diverticular disease of the colon;Primary end point(s): • Rate of patients with episodes of acute diverticulitis and/or complications. An episode of diverticulitis will be defined based on: a) Signs and symptoms (i.e. pain, fever, abdominal tenderness); b) Laboratory tests: erythro-sedimentation rate (ESR), high-specificity C-reactive protein (hs-CRP), increase in white blood cells (WBCs) count; c) Abdominal computerised tomography (CT). ;Timepoint(s) of evaluation of this end point: Extra-visits can be arranged at any time during the study on patient’s request in case of signs and symptoms suggestive of acute diverticulitis and/or complications, in which the investigator will perform further physical examination, laboratory and TC to confirm or exclude this diagnosis (primary variable).

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Secondary

Measure	Time frame
Secondary end point(s): ¿ Global symptoms score (abdominal pain, abdominal discomfort, bloating, flatulence) and changes in bowel habits (number of bowel movements and corresponding defecatory symptoms, i.e. urgency, straining, and feeling of incomplete evacuation); ¿ Rate of patients completely asymptomatic; ¿ Stool consistency, as evaluated by using the Bristol Stool Form Scale (BSFS); ¿ Use of additional medications (acetylsalicylic acid, paracetamol, antispastics, laxatives, antidiarrhoics); ¿ Number of medical consultations; ¿ Working days lost; ¿ Quality of life (Short-Form 36) ¿ Adverse Events (AEs) and Treatment Emergent AEs (TEAEs) occurring at any time during the study; ¿ Vital signs (blood pressure, heart rate, body mass index, body temperature); ¿ Laboratory tests (haematology and blood chemistry); ¿ Physical examination.;Timepoint(s) of evaluation of this end point: At each visit. The laboratory tests will be performed at the screening visit, after 6, 12, 18 and 24 months of treatment.	—

Measure

Time frame

Secondary end point(s): ¿ Global symptoms score (abdominal pain, abdominal discomfort, bloating, flatulence) and changes in bowel habits (number of bowel movements and corresponding defecatory symptoms, i.e. urgency, straining, and feeling of incomplete evacuation); ¿ Rate of patients completely asymptomatic; ¿ Stool consistency, as evaluated by using the Bristol Stool Form Scale (BSFS); ¿ Use of additional medications (acetylsalicylic acid, paracetamol, antispastics, laxatives, antidiarrhoics); ¿ Number of medical consultations; ¿ Working days lost; ¿ Quality of life (Short-Form 36) ¿ Adverse Events (AEs) and Treatment Emergent AEs (TEAEs) occurring at any time during the study; ¿ Vital signs (blood pressure, heart rate, body mass index, body temperature); ¿ Laboratory tests (haematology and blood chemistry); ¿ Physical examination.;Timepoint(s) of evaluation of this end point: At each visit. The laboratory tests will be performed at the screening visit, after 6, 12, 18 and 24 months of treatment.

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Countries

Italy

Contacts

Public ContactFlavia Baruzzi

LB Research

flavia.baruzzi@lbresearch.it0317372218

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026