Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares

Phase 3

Completed

• Conditions: Diverticular Disease
• Interventions: Drug: mesalamine; Other: placebo

• Registration Number: NCT01120340
• Lead Sponsor: SOFAR S.p.A.

Brief Summary

The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up.

The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• age ≥ 18 years
• both males and females patients
• positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare.
• patients who have given their free and informed consent

Exclusion Criteria

• complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding)
• ascertained hypersensitivity to the salicylates
• any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial
• clinically significant renal or hepatic impairment
• esophageal, gastric or duodenal ulcer within 30 days prior to randomisation
• patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)
• treatment with any investigational drug within the previous 30 days
• treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets
• recent history or suspicion of alcohol abuse or drug addiction
• patients who become unable to conform to protocol
• patients with ascertained pregnancy
• previous participation in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesalamine	mesalamine	Posology: mesalamine: 1,6 g/die for ten days every month for 24 months
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
diverticulitis relapse	24 months

Trial Locations

Locations (17)

Ospedale Maggiore; 🇮🇹 Crema, Cremona, Italy

Ospedale di Garbagnate M.se; 🇮🇹 Garbagnate Milanese, Milano, Italy

Ospedale C. Borella; 🇮🇹 Giussano, Milano, Italy

Ospedale di Desio; 🇮🇹 Desio, Milano, Italy

Ospedale Civile; 🇮🇹 Legnano, Milano, Italy

Policlinico di Monza; 🇮🇹 Monza, Monza-Brianza, Italy

Ospedale A. Manzoni; 🇮🇹 Lecco, Italy

Ospedale S. Chiara; 🇮🇹 Trento, Italy

Azienda ULSS; 🇮🇹 Belluno, Italy

Poliambulanza; 🇮🇹 Brescia, Italy

Ospedale G. Bosco; 🇮🇹 Torino, Italy

Ospedale Maria Vittoria; 🇮🇹 Torino, Italy

Ospedale Molinette; 🇮🇹 Torino, Italy

Ospedale di Seriate; 🇮🇹 Seriate, Bergamo, Italy

Ospedale di Esine; 🇮🇹 Esine, Brescia, Italy

A.O. G. Salvini; 🇮🇹 Rho (MI), Milano, Italy

Ospedale S. Antonio Abate; 🇮🇹 Gallarate, Varese, Italy