The role of a hiatal hernia on the efficacy of anti-TLESR therapy in patients with gastroesophageal reflux disease

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003418-16-NL

Enrollment

Registered

2006-07-21

Start date

2007-02-14

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

Gastroesophageal reflux disease

Interventions

Trade Name: Lioresal Product Name: baclofen Product Code: M03BX01 Pharmaceutical Form: Tablet CAS Number: 1134-47-0 Current Sponsor code: Bac04018 Other descriptive name: baclofen Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - GERD patients (M/F) - 18-70 years - typical heartburn symptoms - daily use of PPI's 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: - gastroduodenal surgery in history - epilepsy in family history - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effect of baclofen compared to placebo on the occurrence of gastroesophageal reflux in GERD patients with or without hiatal hernia.;Secondary Objective: To assess reflux symptoms in the selected patient group;Primary end point(s): The rate of acid and non-acid reflux episodes measured by impedance.	—

Countries

Netherlands

Outcome results

None listed

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