Collection and characterization of gastrointestinal fluids in different populations and conditions

Collection and characterization of gastrointestinal fluids in different populations and conditions - No abbreviated title

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000324-19-BE

Enrollment

Registered

2014-08-29

Start date

2014-09-18

Completion date

Unknown

Last updated

2024-06-10

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

Conditions

healthy human volunteers (administration of a proton-pump inhibitor)

Interventions

Trade Name: Nexiam 40 mg maagsapresistente tabletten Product Name: Nexiam Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Esomeprazole CAS Number: 217087-09-7 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy human volunteers (age: 18 - 80 years) 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - (possible) pregnancy - frequent exposure to xrays during the past year - HIB, HBV, HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: This study is part of a larger study which aims to collect and characterise stomach and duodenal fluids in different populations and conditions. The part of the study concerned for the EudraCT file is the test condition in which the effect of proton-pomp inhibtor use on the composition of gastrointestinal fluids of healthy human volunteers is investigated. ;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: This study is part of a larger study which aims to collect and characterise stomach and duodenal fluids in different populations and conditions. The part of the study concerned for the EudraCT file is the test condition in which the effect of proton-pomp inhibtor use on the composition of gastrointestinal fluids of healthy human volunteers is investigated. ;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactDrug Delivery & Disposition

KU Leuven

jens.vandenabeele@pharm.kuleuven.be+3216379105

Outcome results

None listed

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