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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02001727
Other study ID # s-20110054-97/262
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 16, 2013
Last updated November 19, 2014
Start date March 2012
Est. completion date February 2015

Study information

Verified date November 2014
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

Aims:

1. Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on the prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on dyspepsia related health-care consumption and quality of life.

2. To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination of these conditions and the effect on quality of life, prognosis and dyspepsia-related health care expenditure.

Methods:

In 1998-99 20.000 individuals, age 40-65 years, identified by their civil registration number, were allocated by a computerized randomized procedure to HP-screening group and control group. All participants received a questionnaire at inclusion, 1-year and 5-year and now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life. In addition we will obtain information from registers on, comorbidity, use of endoscopies and prescription medication. An economic evaluation is done alongside the randomized trial.

The primary unscreened group is invited to HP test (13C-urea breath-test) in order to analyze the effect of HP-screening according to HP-status

Expected results:

The study will provide information on the long-term effect of HP-screening and eradication in a population. The study will provide information about the long-term effect on incidence of peptic ulcer in an aging population that is likely to have an increased consumption of ASA and NSAID. Furthermore the study will generate knowledge about the long-term prognosis of dyspepsia and reflux in the population (dyspepsia and reflux. Preliminary results from the 5-yr follow-up (13) showed that is has a great influence on quality of life and the dyspepsia-related health care consumption, whether the individual has solely reflux, solely dyspepsia or a combination of both symptoms.

Long-term follow-up and further analyses of these findings could have great impact on management and treatment of individuals with symptoms. It is important to focus on groups; in which the symptoms have the greatest influence on quality of life of the individual. This finding has not been displayed in other studies.


Description:

Questionnaire:

Information on abdominal symptoms (GRSR: Gastrointestinal symptom rating scale, rate of symptoms, quality of life (SF-36, EQ-5D-5L), consumption of ulcer drugs including over the counter drugs, hospital admissions, dyspepsia-related sick leave days, consultations and comorbidity). A reminder is sent out 2 weeks after the first contact.

Register data:

OPED (Odense Pharmaca-epidemiological Database): Information on reimbursable ulcer drugs, ASA, NSAID and HP-eradication therapy. The Regional Hospital discharge Register: Information based on International Classification of Diseases (ICD). Information on ulcer-related admissions, out-patient ulcer diagnosis and comorbidity, use of upper gastrointestinal endoscopy.

HP-test unscreened group:

Invitation of the primary unscreened group to HP test (13C-urea breath-test) in order to analyze the effect of HP-screening according to HP-status. Instruments: automated breath 13Co2 analyser- Isotope ratio mass spectrometer.

Almost all persons are infected with HP during childhood. Infection with the bacteria in adulthood is rare. Only few persons spontaneously turn HP-negative. From OPED we will know which individuals who have been prescribed HP-eradication treatment. Thus the participants in the control group, who are HP-positive at 12-yr follow-up, have had the infection the whole period. Provided they have not received HP-eradication treatment, those who are tested HP-negative have been so the whole period.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10000
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 52 Years to 75 Years
Eligibility Inclusion Criteria:

- Individuals participating in 5 year follow-up

Exclusion Criteria:

- Individuals not participating in 5 year follow-up

- Moved outside the Region of Southern Denmark or with an unknown address

- Individuals who died

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
13C-Urea breath test for Helicobacter Pylori

Questionaire


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Odense University Hospital Region of Southern Denmark, University of Southern Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary Economic Evaluation The overall endpoint is expenditure in Danish kroner (on ulcer drugs, upper gastrointestinal endoscopy, GP consultations, hospital admissions related to peptic ulcer).
Data on resource consumption of these services and procedures is multiplied with relevant unit prices, from the Danish Medicines Agency and the Danish National Board of Health, to assess a health-cost endpoint.
twelve years No
Secondary Frequency of symptoms (dyspepsia, reflux) twelve years No
Secondary Drug consumption Consumption of ulcer drugs including over the counter drugs Twelve years No
Secondary Quality of life twelve years No
Secondary Incidence of esophagus- and gastric cancer Twelve years No
Secondary Upper gastrointestinal endoscopy / X-ray examinations of esophagus and gastric ventricle. Twelve Years No
Secondary Frequency of peptic ulcers incl. complicated ulcers Twelve years No
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