Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

Study Overview
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Brief Summary
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Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD) (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies had several problems including inclusion criteria, randomization methods, and placebo medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed randomized double blind case-control study.

Official Title
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Randomized Controlled Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

Conditions
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Laryngopharyngeal Reflux Disease

Intervention / Treatment
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* Drug: Motilitone
* Drug: Pantoprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 65 years Reflux Symptom Index (RSI) > 7 and, Reflux Finding Score (RFS) > 13 Exclusion Criteria Taken proton pump inhibitor within 3months Taken steroid within 3months Pregnancy Breast feeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proton pump inhibitor + prokinetics<br>Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with prokinetics (Motilitone, 30mg, 1T, TID) for 3months. | Drug: Motilitone<br>* 30mg, 1 tablet, 3 times a day<br>Drug: Pantoprazole<br>* 40mg, 1 tablet, 1time a day<br>|
| Placebo Comparator: Proton pump inhibitor + placebo<br>Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with placebo (Motilitone, 30mg, 1T, TID) for 3months. | Drug: Pantoprazole<br>* 40mg, 1 tablet, 1time a day<br>Drug: Placebo<br>* 30mg, 1 tablet, 3 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux symptom index (questionnaire) | Reflux symptom index is validated questionnaire for laryngopharyngeal reflux disease. It consists of 9 items, and scale of each item ranges from 0 to 5 with maximal total score of 45. | 1 month after medication | 
| Reflux finding score (scoring of laryngeal stroboscopy finding score) | Reflux finding score is an 8-item clinical severity scale based on findings during laryngeal stroboscopy. The scale ranges from 0 (no abnormal findings) to a maximum of 26 (worst score possible). | 1 month after medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux symptom index (questionnaire) | Reflux symptom index is validated questionnaire for laryngopharyngeal reflux disease. It consists of 9 items, and scale of each item ranges from 0 to 5 with maximal total score of 45. | 3 months after medication | 
| Reflux finding score (scoring of laryngeal stroboscopy finding score) | Reflux finding score is an 8-item clinical severity scale based on findings during laryngeal stroboscopy. The scale ranges from 0 (no abnormal findings) to a maximum of 26 (worst score possible). | 3 months after medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngopharyngeal reflux disease, prokinetics, proton pump inhibitor