Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000521426
Ethics application status
Approved
Date submitted
7/10/2007
Date registered
10/10/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The prevalence of Helicobacter pylori infection in patients with peptic ulcer disease complicated by haemorrhage after assumption of nonsteroidal anti-inflammatory drugs
Scientific title
The prevalence of Helicobacter pylori (Hp) infection in patients consecutively admitted during a 12-month period to the emergency unit of the A. Cardarelli Hospital of Naples for peptic ulcer disease complicated by haemorrhage after assumption of nonsteroidal anti-inflammatory drugs (NSAIDs): EMOFANS Study
Universal Trial Number (UTN)
Trial acronym
EMOFANS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Helicobacter pylori infection and NSAIDs use in patients with peptic ulcer disease complicated by haemorrhage 2431 0
Condition category
Condition code
Oral and Gastrointestinal 2533 2533 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study was planned to provide further information on the role of Hp in the pathogenesis of peptic ulcer disease complicated by haemorrhage in patients chronically or occasionally treated with NSAIDs. Data in literature are conflicting because studies were conducted by using different definitions of “NSAID user”, and with different methods for the detection of Hp infection. On the basis of the number of patients observed in our Unit during the previous 2 years, we plan to enrol 80 patients in 12 months.
Intervention code [1] 2153 0
Not applicable
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3434 0
Prevalence of Hp infection in patients with peptic ulcer disease complicated by haemorrhage after assumption of NSAIDs
Timepoint [1] 3434 0
During the in-hospital stay
Secondary outcome [1] 5709 0
Seroprevalence of anti-Cytotoxin-associated antigen A (CagA) antibodies
Timepoint [1] 5709 0
During the in-hospital stay
Secondary outcome [2] 5710 0
Identification of Hp stool antigen. For this purpose, a commercial kit (ImmunoCard STAT! HpSA; Meridian Bioscience Inc., Cincinnati, Ohio) will be used in this study.
Timepoint [2] 5710 0
During the in-hospital stay
Secondary outcome [3] 5711 0
The prevalence of NSAIDs users among all patients with peptic ulcer disease complicated by haemorrhage admitted to the emergency unit of the A. Cardarelli Hospital of Naples during a 12-month observation period
Timepoint [3] 5711 0
During the in-hospital stay
Secondary outcome [4] 5712 0
Incidence of peptic ulcer disease complicated by haemorrhage after assumption of NSAIDs in our cohort of patients compared to that observed in Italy and reported in the "Rete Nazionale di Farmacovigilanza (http://www.aifa.gov.it)" database of the same time period
Timepoint [4] 5712 0
During the in-hospital stay

Eligibility
Key inclusion criteria
Patients with peptic ulcer disease complicated by haemorrhage (Hematemesis, melena, ematochezia, or with other clinical signs of blood loss - i.e., hemodynamic instability with hypotension and tachycardia) within 72 hours before admission;
Continuative or occasional use of nonsteroidal anti-inflammatory drugs within 30 days before admission;
Ulcer with a diameter of at least 5 mm;
Ability to understand and follow the protocol requirements;
Having given written informed consent form for study participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients in treatment with antibiotics and proton-pump inhibitors within 4 weeks before the enrolment;
Patients with upper gastrointestinal neoplastic ulcer

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 617 0
Italy
State/province [1] 617 0

Funding & Sponsors
Funding source category [1] 2682 0
Hospital
Name [1] 2682 0
AORN A. Cardarelli
Country [1] 2682 0
Italy
Primary sponsor type
Individual
Name
Dr. Antonio Balzano
Address
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country
Italy
Secondary sponsor category [1] 2426 0
Individual
Name [1] 2426 0
Dr. Annamaria Nicchia
Address [1] 2426 0
AORN A. Cardarelli
UOC di Farmacia
Via A. Cardarelli 9
80131 Napoli
Country [1] 2426 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4610 0
Comitato Etico AORN "A.Cardarelli"
Ethics committee address [1] 4610 0
Ethics committee country [1] 4610 0
Italy
Date submitted for ethics approval [1] 4610 0
Approval date [1] 4610 0
03/10/2007
Ethics approval number [1] 4610 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28094 0
Address 28094 0
Country 28094 0
Phone 28094 0
Fax 28094 0
Email 28094 0
Contact person for public queries
Name 11251 0
Dott. Francesco Manguso
Address 11251 0
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country 11251 0
Italy
Phone 11251 0
+39-081-7474034
Fax 11251 0
+39-081-7474034
Email 11251 0
[email protected]
Contact person for scientific queries
Name 2179 0
Dott. Francesco Manguso
Address 2179 0
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country 2179 0
Italy
Phone 2179 0
+39-081-7474034
Fax 2179 0
+39-081-7474034
Email 2179 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.