Diverticular DiseasePhase 3DIV-01/04NCT01120340
Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
A Phase 3 study testing mesalamine in people with Diverticular Disease, run by SOFAR S.p.A. at 17 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease
- What is being tested?
- mesalamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 17 sitesItaly
- Study dates
- Oct 2005to Nov 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites
Azienda ULSS
Belluno
Poliambulanza
Brescia
Ospedale Maggiore
Crema, Cremona
Ospedale di Desio
Desio, Milano
Ospedale di Esine
Esine, Brescia
Ospedale S. Antonio Abate
Gallarate, Varese
Ospedale di Garbagnate M.se
Garbagnate Milanese, Milano
Ospedale C. Borella
Giussano, Milano
Ospedale A. Manzoni
Lecco
Ospedale Civile
Legnano, Milano
Policlinico di Monza
Monza, Monza-Brianza
A.O. G. Salvini
Rho (MI), Milano, 20017
Ospedale di Seriate
Seriate, Bergamo
Ospedale G. Bosco
Torino
Ospedale Maria Vittoria
Torino
Ospedale Molinette
Torino
Ospedale S. Chiara
Trento
About this study
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.
- Conditions
- Diverticular Disease
- Being tested
- mesalamine, placebo
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesalamineDrug
mesalamine: 1.6 g/die for ten days/month until 24 months
placeboOther
2 pills/day for ten days/month until 24 months
| Study group | Role | What they receive |
|---|---|---|
| mesalamine | Active comparator | Posology: mesalamine: 1,6 g/die for ten days every month for 24 months Receives: Drug: mesalamine |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
diverticulitis relapse
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startOct 2005
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diverticular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOFAR S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120340
- Sponsor's protocol ID
- Sofar
- Acronym
- DIV-01/04
- Status last verified
- Sep 2013
- First submitted
- 5 May 2010
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23754545
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
- ClinicalTrials.gov ID
- NCT01120340
- Acronym / sponsor ID
- DIV-01/04 / Sofar
- Conditions
- Diverticular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- SOFAR S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesalamine | Active comparator | Drug: mesalaminePosology: mesalamine: 1,6 g/die for ten days every month for 24 months |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesalaminemesalamine: 1.6 g/die for ten days/month until 24 months | Drug | mesalamine |
| placebo2 pills/day for ten days/month until 24 months | Other | placebo |
Primary outcome
diverticulitis relapse
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Derived from this study: PubMed 23754545Parente 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mesalamine in people with Diverticular Disease, run by SOFAR S.p.A. at 17 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diverticulitis relapse (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01120340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.