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

Sponsor

SOFAR S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01120340

Collaborator

(none)

105

Enrollment

Locations

Arms

Duration (Months)

6.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticular Disease	Drug: mesalamine Other: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: placebo	Other: placebo 2 pills/day for ten days/month until 24 months

Arm

Intervention/Treatment

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

Placebo Comparator: placebo

Other: placebo

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

Outcome Measures

Primary Outcome Measures

diverticulitis relapse [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale di Seriate	Seriate	Bergamo	Italy
2	Ospedale di Esine	Esine	Brescia	Italy
3	Ospedale Maggiore	Crema	Cremona	Italy
4	Ospedale di Desio	Desio	Milano	Italy
5	Ospedale di Garbagnate M.se	Garbagnate Milanese	Milano	Italy
6	Ospedale C. Borella	Giussano	Milano	Italy
7	Ospedale Civile	Legnano	Milano	Italy
8	A.O. G. Salvini	Rho (MI)	Milano	Italy	20017
9	Policlinico di Monza	Monza	Monza-Brianza	Italy
10	Ospedale S. Antonio Abate	Gallarate	Varese	Italy
11	Azienda ULSS	Belluno		Italy
12	Poliambulanza	Brescia		Italy
13	Ospedale A. Manzoni	Lecco		Italy
14	Ospedale G. Bosco	Torino		Italy
15	Ospedale Maria Vittoria	Torino		Italy
16	Ospedale Molinette	Torino		Italy
17	Ospedale S. Chiara	Trento		Italy

Sponsors and Collaborators

SOFAR S.p.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SOFAR S.p.A.

ClinicalTrials.gov Identifier:

NCT01120340

Other Study ID Numbers:

Sofar

First Posted:

May 10, 2010

Last Update Posted:

Sep 18, 2013

Last Verified:

Sep 1, 2013

Additional relevant MeSH terms:

Diverticular Diseases

Diverticulum

Mesalamine

Study Results

No Results Posted as of Sep 18, 2013