OBJECTIVE: To evaluate the efficacy, safety and tolerability of fixed dose combination of @entity34070 (enteric-coated, EC) 20 mg + @entity2211 (sustained release, SR) 30 mg for treatment of @entity8823 ( @entity8823 ). DESIGN: A prospective, single centre, open-label, non-comparative, observational study SETTING: The study was conducted at an otolaryngology clinic in India between May 2012 and November 2012. @entity1 : @entity1 (>18 yrs) with suspicious LPR-related symptoms, @entity304 ( @entity304 ) score >13 and @entity51 ( @entity51 ) >7, willing to undergo rigid laryngoscopy and requiring fixed dose combination of @entity34070 (enteric-coated, EC) 20 mg + @entity2211 (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 @entity34070 (enteric-coated, EC) 20 mg + @entity2211 (sustained release, SR) 30 mg capsule treatment was given for a total duration of 90 days and efficacy was assessed by the change in @entity51 and @entity304 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 @entity1 were enrolled and completed the study. After 12 weeks of fixed dose combination of @entity34070 (enteric-coated, EC) 20 mg + @entity2211 (sustained release, SR) 30 mg capsule treatment there was a significant change in mean @entity304 scores [mean (SD) @entity304 : 19.18 (3.24) at baseline to 2.52 (2.31) at end of study; (p<0.0001)] as well as mean @entity51 score [mean (SD) @entity51 : 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 @entity1 during the study period. CONCLUSION: Twelve weeks of treatment with combination of fixed dose combination of @entity34070 (enteric-coated, EC) 20 mg + @entity2211 (sustained release, SR) 30 mg capsule significantly improved reflux symptoms in @entity1 with LPR. The combination was found to be safe and well tolerated.

An Open Label, Prospective, Single Centre Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of @entity34070 (Enteric-Coated, EC) 20 mg + XXXX (Sustained Release, SR) 30 mg Capsule in Treatment of @entity1 with @entity8823 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity34070 :: ('MESH:D064750', 'Chemical') :: ['Rabeprazole'] @entity304 :: ('MESH:D010302', 'Disease') :: ['RSI', 'reflux symptom index'] @entity51 :: ('MESH:D009461', 'Disease') :: ['reflux finding score', 'RFS'] @entity2211 :: ('MESH:D004294', 'Chemical') :: ['Domperidone'] @entity8823 :: ('MESH:D057045', 'Disease') :: ['LPRD', 'laryngopharyngeal reflux disease']
@entity2211 :: (MESH:D004294,Chemical) :: ['Domperidone']
