NCT01120340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

6.1 years

First QC Date

May 5, 2010

Last Update Submit

September 17, 2013

Conditions

Diverticular Disease

Outcome Measures

Primary Outcomes (1)

  • diverticulitis relapse

    24 months

Study Arms (2)

mesalamine

ACTIVE COMPARATOR

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

Drug: mesalamine

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

mesalamineDRUG

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

mesalamine
placeboOTHER

2 pills/day for ten days/month until 24 months

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Ospedale di Seriate

Seriate, Bergamo, Italy

Location

Ospedale di Esine

Esine, Brescia, Italy

Location

Ospedale Maggiore

Crema, Cremona, Italy

Location

Ospedale di Desio

Desio, Milano, Italy

Location

Ospedale di Garbagnate M.se

Garbagnate Milanese, Milano, Italy

Location

Ospedale C. Borella

Giussano, Milano, Italy

Location

Ospedale Civile

Legnano, Milano, Italy

Location

A.O. G. Salvini

Rho (MI), Milano, 20017, Italy

Location

Policlinico di Monza

Monza, Monza-Brianza, Italy

Location

Ospedale S. Antonio Abate

Gallarate, Varese, Italy

Location

Azienda ULSS

Belluno, Italy

Location

Poliambulanza

Brescia, Italy

Location

Ospedale A. Manzoni

Lecco, Italy

Location

Ospedale G. Bosco

Torino, Italy

Location

Ospedale Maria Vittoria

Torino, Italy

Location

Ospedale Molinette

Torino, Italy

Location

Ospedale S. Chiara

Trento, Italy

Location

Related Publications (1)

  • 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.

    PMID: 23754545DERIVED

MeSH Terms

Conditions

Diverticular Diseases

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 10, 2010

Study Start

October 1, 2005

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

IT(17)