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Evaluation of the role of mesalazine in the treatment of diverticular disease of the colon and irritable colon syndrome: A randomised double blind placebo controlled clinical study - ND

Evaluation of the role of mesalazine in the treatment of diverticular disease of the colon and irritable colon syndrome: A randomised double blind placebo controlled clinical study - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004228-22-IT
Enrollment
Unknown
Registered
2009-05-06
Start date
2008-12-15
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Irritable bowel Syndrome Diverticular disease of the colon MedDRA version: 9.1 Level: LLT Classification code 10009993 MedDRA version: 9.1 Level: LLT Classification code 10023004

Interventions

Trade Name: PENTACOL 800 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Mesalazine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800- Pharmaceu

Sponsors

SOFAR SPA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - males and females age > 45 years -first endoscopic and clinic diagnosis of symptomatic, uncomplicated diverticular disease of the colon OR - first endoscopic and clinic diagnosis of Irritable Bowel Syndrome -written consent -ability to understand all the study procedures 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

Exclusion criteria: -previous therapy for diverticular disease or IBS -rectal bleeding -regular assuntion of cardioaspirin,NSAID, antibiotisc, probiotics, cortison-based drugs in the previuous month -allergy to salicilates -pregnancy or lactation -IBD`s -acute diverticulitis -impossibility to give a written consent or to understand all the protocol rules

Design outcomes

Primary

MeasureTime frame
Main Objective: - to evaluate the efficacy of mesalazine in the improvement of the clinical condition of the two study disease. - to evaluate the role of mesalazine in the modification of the histologic pattern of the colonic mucosa.;Secondary Objective: - to evaluate the importance of flogosis in the pathogenesis and clinc of diverticular disease of the colon and of the irritable bowel syndrome - correlation between the histologic evidence and symptoms after the study treatment taking.;Primary end point(s): improvement of the symptoms of the two study diseases.—

Countries

Italy

Outcome results

None listed

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