Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
NCT ID: NCT01120340
Last Updated: 2013-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
105 participants
INTERVENTIONAL
2005-10-31
2011-11-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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mesalamine
Posology: mesalamine: 1,6 g/die for ten days every month for 24 months
mesalamine
mesalamine: 1.6 g/die for ten days/month until 24 months
placebo
placebo
2 pills/day for ten days/month until 24 months
Interventions
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mesalamine
mesalamine: 1.6 g/die for ten days/month until 24 months
placebo
2 pills/day for ten days/month until 24 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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SOFAR S.p.A.
INDUSTRY
Responsible Party
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Locations
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Ospedale di Seriate
Seriate, Bergamo, Italy
Ospedale di Esine
Esine, Brescia, Italy
Ospedale Maggiore
Crema, Cremona, Italy
Ospedale di Desio
Desio, Milano, Italy
Ospedale di Garbagnate M.se
Garbagnate Milanese, Milano, Italy
Ospedale C. Borella
Giussano, Milano, Italy
Ospedale Civile
Legnano, Milano, Italy
A.O. G. Salvini
Rho (MI), Milano, Italy
Policlinico di Monza
Monza, Monza-Brianza, Italy
Ospedale S. Antonio Abate
Gallarate, Varese, Italy
Azienda ULSS
Belluno, , Italy
Poliambulanza
Brescia, , Italy
Ospedale A. Manzoni
Lecco, , Italy
Ospedale G. Bosco
Torino, , Italy
Ospedale Maria Vittoria
Torino, , Italy
Ospedale Molinette
Torino, , Italy
Ospedale S. Chiara
Trento, , Italy
Countries
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References
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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.
Other Identifiers
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Sofar
Identifier Type: -
Identifier Source: org_study_id