High-dose therapy with Esomeprazol in combination with Baclofen therapy for symptomatic therapy-resistant gastrooesophageal reflux disease. - Nexbac

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000368-10-DE

Enrollment

Registered

2006-03-07

Start date

2006-08-10

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: Nexium 40mg Product Name: Esomeprazol Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Esomeprazol Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with persistent reflux disorder with protone pump inhibitors in standard dose. • Age between 18 – 70 years • unavailable contraindication of medicamentous therapy • none established disfunction of blood-coagulation 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: • Participation on another clinical trial within 4 weeks bevor randomisation • linguistical or mental difficulties understanding • admit incompatibility of study medication • existent or planned pregnancy • clinical significant alterations of blood chemistry • „Alarme symptoms“ such as unintended loss of weight, hematemesis, melaena, icterus • Oesophageal varices. • Tumors of upper gastrointestinal tract

Design outcomes

Primary

Measure	Time frame
Main Objective: Effects of treatment with esomeprazole at twice the standard dose (80 mg), possibly in combination with baclofen, in patients with persistent reflux symptoms after therapeutic elimination of acid reflux following esomeprazole at standard doses?;Secondary Objective: • To what extent is it possible to objectify supposed "treatment failure of proton pump inhibitors“? • Can symptoms be improved? • Does intensified drug therapy with Nexium 80mg have a significant effect on parameters of non-acid reflux (number of liquid refluxes) objectified using impedance measurement? • Does the additional administration of baclofen have an effect on symptoms and the number of liquid refluxes ;Primary end point(s): Effects of treatment with esomeprazole at twice the standard dose (80 mg), possibly in combination with baclofen, in patients with persistent reflux symptoms after therapeutic elimination of acid reflux following esomeprazole at standard doses?	—

Measure

Time frame

Main Objective: Effects of treatment with esomeprazole at twice the standard dose (80 mg), possibly in combination with baclofen, in patients with persistent reflux symptoms after therapeutic elimination of acid reflux following esomeprazole at standard doses?;Secondary Objective: • To what extent is it possible to objectify supposed "treatment failure of proton pump inhibitors“? • Can symptoms be improved? • Does intensified drug therapy with Nexium 80mg have a significant effect on parameters of non-acid reflux (number of liquid refluxes) objectified using impedance measurement? • Does the additional administration of baclofen have an effect on symptoms and the number of liquid refluxes ;Primary end point(s): Effects of treatment with esomeprazole at twice the standard dose (80 mg), possibly in combination with baclofen, in patients with persistent reflux symptoms after therapeutic elimination of acid reflux following esomeprazole at standard doses?

—

Countries

Germany

Outcome results

None listed

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