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

• Conditions: Gastroesophageal reflux disease

• Registration Number: EUCTR2006-000368-10-DE
• Lead Sponsor: Tecnical University of Munich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br> pump inhibitors?<br>• Can symptoms be improved?<br>• Does intensified drug therapy with Nexium 80mg have a significant effect on <br> parameters of non-acid reflux (number of liquid refluxes) objectified using <br> impedance measurement?<br>• Does the additional administration of baclofen have an effect on symptoms and <br> the number of liquid refluxes<br>;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?