Predictors of symptomatic response to pantoprazole in patients with laryngopharyngeal reflux

Completed

• Conditions: Laryngopharyngeal reflux; aryngopharyngeal reflux; Digestive System

• Registration Number: ISRCTN16919107
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-17
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
o seconday outcome measures