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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002067-26-IS

Enrollment

100

Registered

2013-06-21

Start date

2013-07-11

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive oesophagitis

Interventions

Trade Name: Losec (R) Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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. ;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	—

Measure

Time frame

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. ;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

Measure	Time frame
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	—

Countries

Iceland

Contacts

Public ContactEinar Stefan Bjornsson

Landspitali University Hospital

einarsb@landspitali.is

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026