Treatment of extraesophageal manifestations of laryngopharyngeal reflux with Nexium (esomeprazole) 20mg bid, a doubleblind placebo controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004532-43-DE

Enrollment

Registered

2005-11-04

Start date

2006-02-07

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

Patients with laryngopharyngeal reflux symptoms will be treated with PPI or Placebo

Interventions

Trade Name: Nexium mups 20 mg Product Name: Nexium mups 20 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Esomeprazole CAS Number: 119141-88-7 Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 visit two: control examination after 6 weeks visit three: final assessment after 12 weeks	—

Measure

Time frame

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 visit two: control examination after 6 weeks visit three: final assessment after 12 weeks

—

Countries

Germany

Outcome results

None listed

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