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

Primary Purpose

Diverticular Disease

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
mesalamine
placebo
Sponsored by
SOFAR S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diverticular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale di Seriate
  • Ospedale di Esine
  • Ospedale Maggiore
  • Ospedale di Desio
  • Ospedale di Garbagnate M.se
  • Ospedale C. Borella
  • Ospedale Civile
  • A.O. G. Salvini
  • Policlinico di Monza
  • Ospedale S. Antonio Abate
  • Azienda ULSS
  • Poliambulanza
  • Ospedale A. Manzoni
  • Ospedale G. Bosco
  • Ospedale Maria Vittoria
  • Ospedale Molinette
  • Ospedale S. Chiara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

mesalamine

placebo

Arm Description

Posology: mesalamine: 1,6 g/die for ten days every month for 24 months

Outcomes

Primary Outcome Measures

diverticulitis relapse

Secondary Outcome Measures

Full Information

First Posted
May 5, 2010
Last Updated
September 17, 2013
Sponsor
SOFAR S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01120340
Brief Title
Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
Acronym
DIV-01/04
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOFAR S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticular Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mesalamine
Arm Type
Active Comparator
Arm Description
Posology: mesalamine: 1,6 g/die for ten days every month for 24 months
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
mesalamine
Intervention Description
mesalamine: 1.6 g/die for ten days/month until 24 months
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
2 pills/day for ten days/month until 24 months
Primary Outcome Measure Information:
Title
diverticulitis relapse
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ospedale di Seriate
City
Seriate
State/Province
Bergamo
Country
Italy
Facility Name
Ospedale di Esine
City
Esine
State/Province
Brescia
Country
Italy
Facility Name
Ospedale Maggiore
City
Crema
State/Province
Cremona
Country
Italy
Facility Name
Ospedale di Desio
City
Desio
State/Province
Milano
Country
Italy
Facility Name
Ospedale di Garbagnate M.se
City
Garbagnate Milanese
State/Province
Milano
Country
Italy
Facility Name
Ospedale C. Borella
City
Giussano
State/Province
Milano
Country
Italy
Facility Name
Ospedale Civile
City
Legnano
State/Province
Milano
Country
Italy
Facility Name
A.O. G. Salvini
City
Rho (MI)
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Facility Name
Policlinico di Monza
City
Monza
State/Province
Monza-Brianza
Country
Italy
Facility Name
Ospedale S. Antonio Abate
City
Gallarate
State/Province
Varese
Country
Italy
Facility Name
Azienda ULSS
City
Belluno
Country
Italy
Facility Name
Poliambulanza
City
Brescia
Country
Italy
Facility Name
Ospedale A. Manzoni
City
Lecco
Country
Italy
Facility Name
Ospedale G. Bosco
City
Torino
Country
Italy
Facility Name
Ospedale Maria Vittoria
City
Torino
Country
Italy
Facility Name
Ospedale Molinette
City
Torino
Country
Italy
Facility Name
Ospedale S. Chiara
City
Trento
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23754545
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.
Results Reference
derived

Learn more about this trial

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

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