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Trial registered on ANZCTR


Registration number
ACTRN12609000045213
Ethics application status
Approved
Date submitted
10/10/2008
Date registered
20/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multivariate analysis of predictors for severity of mucosal lesions in patients with gastro-oesophageal reflux symptoms: a clinical, epidemiological and endoscopic survey
Scientific title
Multivariate analysis of predictors for severity of mucosal lesions in patients with gastro-oesophageal reflux symptoms: a clinical, epidemiological and endoscopic survey
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-oesophageal Reflux Disease 3887 0
Condition category
Condition code
Oral and Gastrointestinal 4090 4090 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
Epidemiological study using the Bowel Disease Questionnaire, the Nepean Dyspepsia Index, the Hospital Anxiety and Depression Score, the Patient Assessment of Upper Gastrointestinal Symptom Severity Index, and the ReQuest Patient Diary. The Patient will complete the surveys providing information of their gastointestinal symptoms, psychological and emotional status, lifestyle and sociodemographics. Surveys are mailed in the post at time points zero, 2 months and 6 months.
Intervention code [1] 3617 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4986 0
To assess patients outcome in a routine clinical care setting in a follow-up over 6 months. To determine possible predictors of response/non-response using an overall symptom score, social and demographic factors in patients with reflux symptoms in two big health care centres in a metropolitan area. The outcomes of this study will be evaluated using well-established multiple regression techniques and the statistics program called Statistical Package for the Social Sciences.
Timepoint [1] 4986 0
Estimated time of completion is May 2009. Two interim analysis already were performed in May 2008 and September 2008 on participants which finished the 3 surveys after 6 months.
Secondary outcome [1] 8407 0
Our secondary aim is to evaluate factors which may be implicated in the efficacy of treatment with proton pump inhibitors using an overall symptom score, social and demographic factors in patients with reflux symptoms. The outcomes of this study will be evaluated using well-established multiple regression techniques and the statistics program called Statistical Package for the Social Sciences.
Timepoint [1] 8407 0
Estimated time of completion is May 2009. Two interim analysis already were performed in May 2008 and September 2008 on participants which finished the 3 surveys after 6 months.

Eligibility
Key inclusion criteria
primary complaints are reflux symptoms (heartburn, regurgitation)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with significant co-morbidities, poor surgical candidate, unstable psychiatric disorder, unable to sign consent and complete questionnaires.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4083 0
Hospital
Name [1] 4083 0
Royal Adelaide Hospital
Address [1] 4083 0
North Tce
Adelaide, SA, 5000
Country [1] 4083 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Nycomed GmbH (prior Altana Pharma)
Address
Byk-Gulden-Str. 2
78467 Konstanz
Country
Germany
Secondary sponsor category [1] 3678 0
Hospital
Name [1] 3678 0
Royal Adelaide Hospital
Address [1] 3678 0
North Tce
Adelaide, SA, 5000
Country [1] 3678 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6153 0
Human Research Ethics Committee Of Royal Adelaide Hospital
Ethics committee address [1] 6153 0
North Tce
Adelaide, SA 5000
Ethics committee country [1] 6153 0
Australia
Date submitted for ethics approval [1] 6153 0
Approval date [1] 6153 0
Ethics approval number [1] 6153 0

Summary
Brief summary
Clinical observations suggest that the endoscopic grade of reflux oesophagitis varies significantly in patients presenting in two different hospitals A and B. These Hospitals are located in socioeconomic diverse areas, which has a big impact in health care utilization and patient’s follow-up. But this difference and a reason have not been studied prospectively so far. This is an epidemiological study using questionnaires for patients with symptoms Gastro-oesophageal Reflux Disease such as heartburn and regurgitation. Symptomatic patients referred for endoscopy will be asked complete the surveys providing information of their gastointestinal symptoms, psychological and emotional status, lifestyle and sociodemographics. Surveys are mailed in the post at time points zero, 2 months and 6 months. The aim is to assess patient’s outcome in a routine clinical care setting in a follow-up over 6 months. We like to determine possible predictors of response/non-response, symptom improvement and efficacy of the common treatment with proton pump inhibitors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29026 0
Address 29026 0
Country 29026 0
Phone 29026 0
Fax 29026 0
Email 29026 0
Contact person for public queries
Name 12183 0
Jane M. Andrews, MD
Address 12183 0
North Tce
GI-Unit, Q7, NW
Adelaide, SA 5000
Country 12183 0
Australia
Phone 12183 0
+61-8-82225207
Fax 12183 0
Email 12183 0
Jane.Andrews@health.sa.gov.au
Contact person for scientific queries
Name 3111 0
Jane M. Andrews, MD
Address 3111 0
North Tce
GI-Unit, Q7, NW
Adelaide, SA 5000
Country 3111 0
Australia
Phone 3111 0
+61-8-82225207
Fax 3111 0
Email 3111 0
Jane.Andrews@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary