Condition category
Digestive System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Gastroesophageal reflux disease (GERD) is a long-term condition where stomach acid comes up into the esophagus (gullet). It is usually caused when the ring of muscle at the bottom of the esophagus is weakened, leading to stomach acid easily being able to leak through. As well as causing heartburn and indigestion, this can lead to discomfort in the throat, hoarseness or voice loss, and cough (laryngeal symptoms) because the stomach acid gradually causes damage to the esophagus. A common treatment for this is a medication called pantoprazole, which decreases the amount of acid produced by the stomach, coupled with lifestyle modifications such as not eating late at night and weight loss. This treatment is generally effective, but it does not work for all patients. This study is going to look at patients suffering from laryngeal symptoms because of GERD (laryngopharyngeal reflux). The aim of this study is to find out whether there are any signs that may be able to predict whether a patient with laryngopharyngeal reflux will respond to pantoprazole and lifestyle modification treatment.

Who can participate?
Adults complaining of hoarseness, sore throat, throat burning/pain, throat clearing, voice loss, cough, excessive throat mucus, globus (feeling of having something stuck in the throat), or choking for at least four weeks in the last three months.

What does the study involve?
All participants are prescribed 40mg pantoprazole to take 30-60 minutes before breakfast and dinner for 12 weeks, and information about how they can change their lifestyle to improve their symptoms. Participants are invited to answer three questionnaires (“Reflux Symptom Index” designed to test for signs of laryngopharyngeal reflux, “GerdQ” developed as a diagnostic tool for GERD patients visiting their doctor about upper GI (esophagus, stomach and first part of the intestine) complaints and “An ad hoc questionnaire” designed by the research team to investigate other possible causes of laryngeal irritation) and laryngoscopy exam (examination of the back of the throat) at the start of the study and then again after four and 12 weeks.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
Hospital Alemán (Argentina)

When is the study starting and how long is it expected to run for?
December 2015 to May 2018

Who is funding the study?
Takeda Pharmaceuticals U.S.A. (USA)

Who is the main contact?
Dr Pablo Luna

Trial website

Contact information



Primary contact

Dr Pablo Luna


Contact details

Hospital Alemán
Av. Pueyrredón 1640
Ciudad Autónoma de Buenos Aires

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Clinical and laryngoscopic predictors of symptomatic response to pantoprazole magnesium in patients with newly diagnosed laryngopharyngeal reflux: a prospective study


Study hypothesis

There are certain clinical and laringoscopic features that may predict response to PPI therapy (pantoprazole magnesium) in patients with suspected laryngopharyngeal reflux.

Ethics approval

Comité de ética independiente Hospital Alemán (Argentina), 18/07/2016, ref: 172

Study design

Prospective observational cohort study

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Laryngopharyngeal reflux


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).

Intervention type


Drug names

Primary outcome measure

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

No seconday outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Hospital Alemán
Av. Pueyrredón 1640
Ciudad Autónoma de Buenos Aires

Sponsor information


Takeda Pharmaceutical Company Limited

Sponsor details

One Takeda Parkway
United States of America

Sponsor type




Funder type


Funder name

Takeda Pharmaceuticals U.S.A.

Alternative name(s)

Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceutical Company Limited, Takeda, TPUSA

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)


United States of America

Results and Publications

Publication and dissemination plan

Planned publication in gastroenterology journals and disseminate the study results on the six months after ended the study.

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes