NCT02533349

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Laryngopharyngeal Reflux Disease

Interventions

Type	Name	Description
DRUG	Motilitone	30mg, 1 tablet, 3 times a day
DRUG	Pantoprazole	40mg, 1 tablet, 1time a day
DRUG	Placebo	30mg, 1 tablet, 3 times a day

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2015-08-26
• Last updated: 2016-06-01

Locations

1 site across 1 country: South Korea