Treatment of extraesophageal manifestations of laryngopharyngeal reflux with Nexium (esomeprazole) 20mg bid, a doubleblind placebo controlled study
- Conditions
- Patients with laryngopharyngeal reflux symptoms will be treated with PPI or Placebo
- Registration Number
- EUCTR2005-004532-43-DE
- Lead Sponsor
- Klinikum Großhadern, ENT-Department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Globus sensation, hoarseness, heartburn, chronic cough, voice weakness, throat clearing, choking episodes, postnasal drip, dysphagia
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
To take proton pump inhibitors or H2-blockers, being under treatment with warfarin, pregnancy oin female patients, history of surgery of the upper aero digestive tract and gastro intestinal tract, age younger than 18
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of the study is to identify whether in patients with atypical symptoms of laryngopharyngeal reflux (LPR) an ex juvantibus treatment with Nexium 20 mgs bid over a period of 3months shows significant improvement in the symptom score compared to patients who receive a placebo for the same period of time.;Secondary Objective: ;Primary end point(s): visit one: Initiation in the study<br>visit two: control examination after 6 weeks<br>visit three: final assessment after 12 weeks
- Secondary Outcome Measures
Name Time Method