Difference between dosages needed of proton pump inhibitors for females and males

Conditions: Erosive oesophagitis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-002067-26-IS

Lead Sponsor: andspitali University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

We plan to recruit 100 patients with endoscopy verified erosive esophagitis, 18 years and older, equally many males and females. These have recently been identified by review of endoscopy reports between 2005 and 2010. Patients on daily PPIs for more than 2 years of PPI therapy will be recruited.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Exclusion criteria are: symptomatic GERD, age> 80 years, lactose intolerance, severe co-morbidities such as malignancy or severe heart or lung disease, alcoholism, H. pylori infection and inability to understand Icelandic.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this work is to identify the percentage of patients/participants for whom the dosage of proton pump inhibitor (PPI) can be lowered without affecting the efficacy of the treatment. Efficacy will be evaluated based on return of symtoms of gastro- esophageal reflux disease. <br>;Secondary Objective: The secondary objective of this work is to identify the percentage of patients/participants for whom the dosage of proton pump inhibitor (PPI) can be lowered without affecting the efficacy of the treatment. Efficacy will be evaluated based on changes in scores on an evaluation scale (Glasgow-Dyspepsia scale). ;Primary end point(s): Willingness to continue on the research dosage at the end of two months, defined as no significant experience of dyspeptic symptoms;Timepoint(s) of evaluation of this end point: At the end of the study period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Significant changes in Glasgow Dispepsia Score and the amount of Rennie-tablets taken at the end of two months;Timepoint(s) of evaluation of this end point: At the end of the study period