Clinical trial NCT01120340: Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diverticular Disease
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: diverticulitis relapse
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seriate
country: Italy
facility: Ospedale di Seriate
state: Bergamo
city: Esine
country: Italy
facility: Ospedale di Esine
state: Brescia
city: Crema
country: Italy
facility: Ospedale Maggiore
state: Cremona
city: Desio
country: Italy
facility: Ospedale di Desio
state: Milano
city: Garbagnate Milanese
country: Italy
facility: Ospedale di Garbagnate M.se
state: Milano
city: Giussano
country: Italy
facility: Ospedale C. Borella
state: Milano
city: Legnano
country: Italy
facility: Ospedale Civile
state: Milano
city: Rho (MI)
country: Italy
facility: A.O. G. Salvini
state: Milano
city: Monza
country: Italy
facility: Policlinico di Monza
state: Monza-Brianza
city: Gallarate
country: Italy
facility: Ospedale S. Antonio Abate
state: Varese
city: Belluno
country: Italy
facility: Azienda ULSS
city: Brescia
country: Italy
facility: Poliambulanza
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Torino
country: Italy
facility: Ospedale G. Bosco
city: Torino
country: Italy
facility: Ospedale Maria Vittoria
city: Torino
country: Italy
facility: Ospedale Molinette
city: Trento
country: Italy
facility: Ospedale S. Chiara
Study officials:
References:
citation: Parente F, Bargiggia S, Prada A, Bortoli A, Giacosa A, Germana B, Ferrari A, Casella G, De Pretis G, Miori G; "Gismi Study Group". Intermittent treatment with mesalazine in the prevention of diverticulitis recurrence: a randomised multicentre pilot double-blind placebo-controlled study of 24-month duration. Int J Colorectal Dis. 2013 Oct;28(10):1423-31. doi: 10.1007/s00384-013-1722-9. Epub 2013 Jun 12.