Overview
Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease
Status:
Unknown status
Unknown status
Trial end date:
2017-01-01
2017-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Samsung Medical CenterTreatments:
Pantoprazole
Proton Pump Inhibitors
Criteria
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