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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120340
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : September 18, 2013
Information provided by (Responsible Party):

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : October 2005
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. diverticulitis relapse [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01120340

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: SOFAR S.p.A. Identifier: NCT01120340     History of Changes
Other Study ID Numbers: Sofar
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents