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

Diverticular Disease Clinical Trial

— DIV-01/04  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120340
• Other study ID #: Sofar
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2010
• Last updated: September 17, 2013
• Start date: October 2005
• Est. completion date: November 2011

Study information

• Verified date: September 2013
• Source: SOFAR S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diverticular Disease
• Diverticulum

Intervention

Drug:
• mesalamine
mesalamine: 1.6 g/die for ten days/month until 24 months

Other:
• placebo
2 pills/day for ten days/month until 24 months

Locations

Country	Name	City	State
Italy	Azienda ULSS	Belluno
Italy	Poliambulanza	Brescia
Italy	Ospedale Maggiore	Crema	Cremona
Italy	Ospedale di Desio	Desio	Milano
Italy	Ospedale di Esine	Esine	Brescia
Italy	Ospedale S. Antonio Abate	Gallarate	Varese
Italy	Ospedale di Garbagnate M.se	Garbagnate Milanese	Milano
Italy	Ospedale C. Borella	Giussano	Milano
Italy	Ospedale A. Manzoni	Lecco
Italy	Ospedale Civile	Legnano	Milano
Italy	Policlinico di Monza	Monza	Monza-Brianza
Italy	A.O. G. Salvini	Rho (MI)	Milano
Italy	Ospedale di Seriate	Seriate	Bergamo
Italy	Ospedale G. Bosco	Torino
Italy	Ospedale Maria Vittoria	Torino
Italy	Ospedale Molinette	Torino
Italy	Ospedale S. Chiara	Trento

Sponsors (1)

Lead Sponsor	Collaborator
SOFAR S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diverticulitis relapse		24 months	Yes