title: An Open Label, Prospective, Single Centre Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Rabeprazole (Enteric-Coated, EC) 20 mg + Domperidone (Sustained Release, SR) 30 mg Capsule in Treatment of Patients with Laryngopharyngeal Reflux Disease.
abstract: OBJECTIVE
  To evaluate the efficacy, safety and tolerability of fixed dose combination of Rabeprazole (enteric-coated, EC) 20 mg + Domperidone (sustained release, SR) 30 mg for treatment of laryngopharyngeal reflux disease (LPRD).
  
  
  METHODS
  A prospective, single centre, open-label, non-comparative, observational study
  
  
  METHODS
  The study was conducted at an otolaryngology clinic in India between May 2012 and November 2012.
  
  
  METHODS
  Patients (>18 yrs) with suspicious LPR-related symptoms, reflux symptom index (RSI) score >13 and reflux finding score (RFS) >7, willing to undergo rigid laryngoscopy and requiring fixed dose combination of Rabeprazole (enteric-coated, EC) 20 mg + Domperidone (sustained release, SR) 30 mg capsule treatment according to the investigator's discretion were eligible for enrolment in the study.
  
  
  METHODS
  Fixed dose combination of Rabeprazole (enteric-coated, EC) 20 mg + Domperidone (sustained release, SR) 30 mg capsule treatment was given for a total duration of 90 days and efficacy was assessed by the change in RFS and RSI score at Day 90. The safety and tolerability of the study drug was assessed by monitoring adverse events, vital signs and physical examination.
  
  
  RESULTS
  Overall, 50 patients were enrolled and completed the study. After 12 weeks of fixed dose combination of Rabeprazole (enteric-coated, EC) 20 mg + Domperidone (sustained release, SR) 30 mg capsule treatment there was a significant change in mean RSI scores [mean (SD) RSI: 19.18 (3.24) at baseline to 2.52 (2.31) at end of study; (p<0.0001)] as well as mean RFS score [mean (SD) RFS: 12.62 (1.48) at baseline to 0.30 (0.51) at end of study; (p<0.0001)]. No adverse event was reported by any patient during the study period.
  
  
  CONCLUSIONS
  Twelve weeks of treatment with combination of fixed dose combination of Rabeprazole (enteric-coated, EC) 20 mg + Domperidone (sustained release, SR) 30 mg capsule significantly improved reflux symptoms in patients with LPR. The combination was found to be safe and well tolerated.
authors.forename: K
authors.initials: K
authors.lastname: Semmanaselvan
authors.forename: Qayum I
authors.initials: QI
authors.lastname: Mukaddam
authors.forename: Manoj
authors.initials: M
authors.lastname: Naik
mesh_terms: D000328:Adult; D000368:Aged; D002214:Capsules; D003692:Delayed-Action Preparations; D004294:Domperidone / Q000627:therapeutic use*; D018492:Dopamine Antagonists / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007194:India; D057045:Laryngopharyngeal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D064750:Rabeprazole / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002214:Capsules; D003692:Delayed-Action Preparations; D018492:Dopamine Antagonists; D054328:Proton Pump Inhibitors; D064750:Rabeprazole; D004294:Domperidone