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
About this trial
This is an interventional prevention trial for Diverticular Disease
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
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
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
We'll reach out to this number within 24 hrs