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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.
ClinicalTrials.gov Identifier:
NCT01120340
First received: May 5, 2010
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Diverticular Disease
Drug: mesalamine
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by SOFAR S.p.A.:

Primary Outcome Measures:
  • diverticulitis relapse [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: October 2005
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120340

Locations
Italy
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 M.se
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
Poliambulanza
Brescia, Italy
Ospedale A. Manzoni
Lecco, Italy
Ospedale Maria Vittoria
Torino, Italy
Ospedale G. Bosco
Torino, Italy
Ospedale Molinette
Torino, Italy
Ospedale S. Chiara
Trento, Italy
Sponsors and Collaborators
SOFAR S.p.A.
  More Information

No publications provided by SOFAR S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov Identifier: NCT01120340     History of Changes
Other Study ID Numbers: Sofar
Study First Received: May 5, 2010
Last Updated: September 17, 2013
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Diverticulum
Pathological Conditions, Anatomical
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014