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

Phase 3

• Conditions: Laryngopharyngeal Reflux Disease
• Interventions: Drug: Pantoprazole; Drug: Motilitone; Drug: Placebo

• Registration Number: NCT02533349
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-26
• Status Verified: 2016-05
• Study Start: 2016-05
• Last Update Submitted: 2016-05-29
• Last Update Posted: 2016-06-01
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton pump inhibitor + placebo	Pantoprazole	Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with placebo (Motilitone, 30mg, 1T, TID) for 3months.
Proton pump inhibitor + placebo	Placebo	Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with placebo (Motilitone, 30mg, 1T, TID) for 3months.
Proton pump inhibitor + prokinetics	Motilitone	Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with prokinetics (Motilitone, 30mg, 1T, TID) for 3months.
Proton pump inhibitor + prokinetics	Pantoprazole	Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with prokinetics (Motilitone, 30mg, 1T, TID) for 3months.

Primary Outcome Measures

Name	Time	Method
Reflux symptom index (questionnaire)	1 month after medication	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.
Reflux finding score (scoring of laryngeal stroboscopy finding score)	1 month after medication	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).

Secondary Outcome Measures

Name	Time	Method
Reflux finding score (scoring of laryngeal stroboscopy finding score)	3 months after medication	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).
Reflux symptom index (questionnaire)	3 months after medication	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of