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Randomised clinical trial: efficacy of the addition of a prokinetic, mosapride citrate, to omeprazole in the treatment of patients with non‐erosive reflux disease – a double‐blind, placebo‐controlled study
Author(s) -
Miwa H.,
Inoue K.,
Ashida K.,
Kogawa T.,
Nagahara A.,
Yoshida S.,
Tano N.,
Yamazaki Y.,
Wada T.,
Asaoka D.,
Fujita T.,
Tanaka J.,
Shimatani T.,
Manabe N.,
Oshima T.,
Haruma K.,
Azuma T.,
Yokoyama T.
Publication year - 2011
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2010.04517.x
Subject(s) - omeprazole , nerd , medicine , placebo , proton pump inhibitor , mosapride , gastroenterology , clinical endpoint , reflux , lansoprazole , randomized controlled trial , gerd , disease , alternative medicine , pathology
Aliment Pharmacol Ther 2011; 33: 323–332 Summary Background Proton pump inhibitors (PPIs) are less effective in non‐erosive reflux disease (NERD) patients than in reflux oesophagitis patients. Whether the addition of prokinetics to PPIs improves NERD patients’ symptoms remains unknown. Aim To evaluate the efficacy of mosapride in NERD patients when used with PPI. Methods A total of 200 NERD patients were randomised to one of two arms: omeprazole (10 mg once daily) plus mosapride citrate (5 mg three times a day) (treatment arm) and omeprazole plus placebo (placebo arm). The primary endpoint was the rate of responders [visual analogue scale (VAS) was zero or <1 cm] after 4 weeks of treatment. The secondary endpoints were changes in the VAS score and the safety profile. Results There was no significant difference between the rates of responders in both arms in intent‐to‐treat (ITT) and per‐protocol (PP) analysis. The change in the VAS score in treatment arm was significantly better than placebo arm in PP analysis (−4.0 ± 0.2 and −3.3 ± 0.2, mean ± S.E.M.) (N.S. in ITT analysis). The rate of adverse events was similar in both groups. Conclusion The addition of mosapride to omeprazole was not more effective than omeprazole alone.