Multivariate analysis of predictors for severity of mucosal lesions in patients with gastro-oesophageal reflux symptoms: a clinical, epidemiological and endoscopic survey

Not Applicable

Completed

• Conditions: Gastro-oesophageal Reflux Disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12609000045213
• Lead Sponsor: ycomed GmbH (prior Altana Pharma)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

primary complaints are reflux symptoms (heartburn, regurgitation)

Exclusion Criteria

patients with significant co-morbidities, poor surgical candidate, unstable psychiatric disorder, unable to sign consent and complete questionnaires.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[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 Measures

Name	Time	Method
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.[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.]