Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares (DIV-01/04)

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.

Study Overview

• Status: Completed
• Conditions: Diverticular Disease
• Intervention / Treatment: Drug: mesalamine; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Belluno, Italy
    • Azienda ULSS
  • Brescia, Italy
    • Poliambulanza
  • Lecco, Italy
    • Ospedale A. Manzoni
  • Torino, Italy
    • Ospedale Maria Vittoria
  • Torino, Italy
    • Ospedale Molinette
  • Torino, Italy
    • Ospedale G. Bosco
  • Trento, Italy
    • Ospedale S. Chiara
  • Bergamo
    • Seriate, Bergamo, Italy
      • Ospedale di Seriate
  • Brescia
    • Esine, Brescia, Italy
      • Ospedale di Esine
  • Cremona
    • Crema, Cremona, Italy
      • Ospedale Maggiore
  • Milano
    • Desio, Milano, Italy
      • Ospedale di Desio
    • Garbagnate Milanese, Milano, Italy
      • Ospedale di Garbagnate M.se
    • Giussano, Milano, Italy
      • Ospedale C. Borella
    • Legnano, Milano, Italy
      • Ospedale Civile
    • Rho (MI), Milano, Italy, 20017
      • A.O. G. Salvini
  • Monza-Brianza
    • Monza, Monza-Brianza, Italy
      • Policlinico di Monza
  • Varese
    • Gallarate, Varese, Italy
      • Ospedale S. Antonio Abate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: placebo; 2 pills/day for ten days/month until 24 months
Active Comparator: mesalamine; Posology: mesalamine: 1,6 g/die for ten days every month for 24 months	Drug: mesalamine; mesalamine: 1.6 g/die for ten days/month until 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
diverticulitis relapse	24 months

Collaborators and Investigators

• Sponsor: SOFAR S.p.A.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (Estimate): May 10, 2010

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: Sofar