Predictors of symptomatic response to pantoprazole in patients with laryngopharyngeal reflux

• Register: ISRCTN
• Last refreshed on: 24 October 2016
• Main ID: ISRCTN16919107
• Date of registration: 17/08/2016
• Prospective Registration: Yes
• Primary sponsor: Takeda Pharmaceutical Company Limited
• Public title: Predictors of symptomatic response to pantoprazole in patients with laryngopharyngeal reflux
• Scientific title: Clinical and laryngoscopic predictors of symptomatic response to pantoprazole magnesium in patients with newly diagnosed laryngopharyngeal reflux: a prospective study
• Date of first enrolment: 01/09/2016
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16919107
• Study type: Observational
• Study design: Prospective observational cohort study (Other)

Countries of recruitment

Argentina

Contacts

• Name: Pablo Luna

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Laryngopharyngeal reflux
Digestive System
Laryngopharyngeal reflux

Intervention(s)

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 late-night meals or eating 2-3 hours before bedtime, head of bed elevation for patients with nocturnal symptoms) and weight loss (for patients who are overweight or or have recently gained weight). as part of their standard care.

On day one of the study, patients evaluated in the otolaryngology unit with laryngopharyngeal reflux symptoms and meet the inclusion criteria will be invited to participate. Following provision of informed consent, patients are required to answer three questionnaires (Reflux symptom index – RSI, GerdQ questionnaire and an ad hoc questionnaire designed by the research team to investigate other possible etiologies of laryngeal irritation). Laryngoscopy, Reflux finding score (RFS) and retro laryngeal reflux score (proposed by the team) will be assessed as standard diagnostic evaluation. An upper gastrointestinal endoscopy will be performed only if patients present frequent typical reflux symptoms (> 2 per week). Los Angeles classification will be used for grading of reflux esophagitis.

After 4 weeks, an Interim Symptom evaluation will be performed (RSI and GerdQ questionnaire will be repeated) and pantoprazole treatment adherence will be evaluated in Gastroenterology unit.

After 12 weeks, patients are re-evaluated in the otolaryngology unit with RSI, GerdQ, and laryngoscopy (RFS and retro laryngeal score).

Primary Outcome(s)

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(s)

No seconday outcome measures

Secondary ID(s)

IISR-2014-100849

Source(s) of Monetary Support

Takeda Pharmaceuticals U.S.A.