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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Samsung Medical Center

Current Primary Outcome:

  • Reflux symptom index (questionnaire) [ Time Frame: 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) [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reflux symptom index (questionnaire) [ Time Frame: 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.
  • Reflux finding score (scoring of laryngeal stroboscopy finding score) [ Time Frame: 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).


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: August 4, 2015
Date Started: May 2016
Date Completion: January 2017
Last Updated: May 29, 2016
Last Verified: May 2016