Laryngopharyngeal reflux Digestive System Laryngopharyngeal reflux
Conditions
Interventions
All participants are receiving pantoprazole magnesium 40 mg (Tecta R) one capsule given orally 30-60 minutes before breakfast and dinner for 12 weeks and education about lifestyle modifications (avoid
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. Chief complaint of hoarseness, sore throat, throat burning/pain, throat clearing, voice loss, cough, excessive throat mucus, globus, or choking for at least 4 weeks in the preceding 3 months
Exclusion criteria
Exclusion criteria: 1. Patients younger than age 18 2. Patients with identifiable laryngeal pathology 3. Upper respiratory tract infection in the past 4 weeks 4. Identifiable allergic causes of laryngitis 5. Previous laryngeal malignancy, surgery or radiotherapy 6. Women of childbearing potential not using an effective contraceptive method 7. Acid-suppressive therapy within the past 4 weeks 8. Hypersensitivity to the active ingredient, or to any of the excipients of the product 9. Patients taking HIV protease inhibitors or methotrexate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients responding to pantoprazole magnesium treatment is determined using Reflux Proportion of patients responding to pantoprazole magnesium treatment is determined using the Reflux symptom index (RSI), GerdQ questionnaire, Laryngoscopy, Reflux finding score (RFS) and retro laryngeal reflux score at baseline, 4 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| No seconday outcome measures | — |
Countries
Argentina
Outcome results
None listed