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Omeprazole and reflux disease - improvement of clinical outcome by genotype-adjusted dosing - GERD-Studie

Omeprazole and reflux disease - improvement of clinical outcome by genotype-adjusted dosing - GERD-Studie

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004650-24-DE
Enrollment
Unknown
Registered
2006-12-13
Start date
2007-03-02
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

gastrooesophageal reflux disease (GERD)

Interventions

Trade Name: omeprazol-ratiopharm NT Product Name: Omeprazole Pharmaceutical Form: Capsule, hard INN or Proposed INN: omeprazole CAS Number: 73590-58-6 Current Sponsor code: none Other descriptive name

Sponsors

IKP
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Reflux Oesophagitis grade A and B Body Mass Index 20-30 Age 20-70 years written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with known sensitivity to omeprazole deficiency of lactase pregnancy no written informed consent

Design outcomes

Primary

MeasureTime frame
Main Objective: To prove the benefit of individualized dosing;Secondary Objective: ;Primary end point(s): endoscopic healing rates—

Countries

Germany

Outcome results

None listed

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