PMID- 29527318
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220316
IS  - 2054-4774 (Print)
IS  - 2054-4774 (Electronic)
IS  - 2054-4774 (Linking)
VI  - 5
IP  - 1
DP  - 2018
TI  - Study for every other day administration of vonoprazan in maintenance treatment 
      of erosive GERD: study protocol for a multicentre randomised cross-over study.
PG  - e000197
LID - 10.1136/bmjgast-2017-000197 [doi]
LID - e000197
AB  - INTRODUCTION: The first drug selected for treatment of gastro-oesophageal reflux 
      disease (GERD) and prevention of the recurrence is a proton pump inhibitor (PPI), 
      but recently, a potassium-competitive acid blocker (P-CAB) was put on the market 
      in Japan. Its onset of effect is faster than PPI, and it takes more than 2 days 
      to recover acid secretion after the withdrawal period. Therefore, unlike PPI, the 
      usefulness of every other day administration or discontinuous administration is 
      expected. METHODS AND ANALYSIS: This study is a prospective, multicentre, 
      open-label, two-period randomised cross-over study to compare the efficacy and 
      safety of PPI every other day administration and P-CAB every other day 
      administration in 120 patients who receive erosive GERD maintenance therapy with 
      PPI. Patients will be randomly allocated to receive 4 weeks P-CAB or PPI followed 
      by 4 weeks cross over, where those on P-CAB will receive PPI and vice versa. The 
      primary endpoint is proportion of asymptomatic patients. Secondary endpoints are 
      suppressive effect of GERD symptoms, proportion of asymptomatic patients at each 
      time point, safety and cost-saving effect of P-CAB every other day 
      administration, compliance with every other day administration, and proportion of 
      asymptomatic patients at the first month of study drug administration. ETHICS AND 
      DISSEMINATION: This study was approved by the National Hospital Organization 
      Central Review Board for Clinical Trials (5 December 2017). DISCUSSION: If P-CAB 
      every other day administration is established as one of GERD maintenance 
      therapies, there is merit in both medical cost reduction and the safety to 
      alleviate elevation in serum gastrin. TRIAL REGISTRATION NUMBER: UMIN000034701.
FAU - Kato, Mototsugu
AU  - Kato M
AD  - Department of Gastroenterology, National Hospital Organization Hakodate National 
      Hospital, Hakodate, Japan.
AD  - Clinical Research Center, National Hospital Organization Nagoya Medical Center, 
      Nagoya, Japan.
FAU - Ito, Noriko
AU  - Ito N
AD  - Clinical Research Center, National Hospital Organization Nagoya Medical Center, 
      Nagoya, Japan.
FAU - Demura, Mamiko
AU  - Demura M
AD  - Department of Clinical Research, Hakodate National Hospital, Hakodate, Japan.
FAU - Kubo, Kimitoshi
AU  - Kubo K
AD  - Department of Gastroenterology, National Hospital Organization Hakodate National 
      Hospital, Hakodate, Japan.
FAU - Mabe, Katsuhiro
AU  - Mabe K
AD  - Department of Gastroenterology, National Hospital Organization Hakodate National 
      Hospital, Hakodate, Japan.
FAU - Harada, Naohiko
AU  - Harada N
AD  - Department of Gastroenterology, National Hospital Organization Kyushu Medical 
      Center, Fukuoka, Japan.
LA  - eng
PT  - Journal Article
DEP - 20180216
PL  - England
TA  - BMJ Open Gastroenterol
JT  - BMJ open gastroenterology
JID - 101660690
PMC - PMC5841500
OTO - NOTNLM
OT  - acid
OT  - gastric acid secretion
OT  - gastro-esophageal reflux disease
COIS- Competing interests: None declared.
EDAT- 2018/03/13 06:00
MHDA- 2018/03/13 06:01
PMCR- 2018/02/16
CRDT- 2018/03/13 06:00
PHST- 2017/12/28 00:00 [received]
PHST- 2018/01/22 00:00 [revised]
PHST- 2018/01/26 00:00 [accepted]
PHST- 2018/03/13 06:00 [entrez]
PHST- 2018/03/13 06:00 [pubmed]
PHST- 2018/03/13 06:01 [medline]
PHST- 2018/02/16 00:00 [pmc-release]
AID - bmjgast-2017-000197 [pii]
AID - 10.1136/bmjgast-2017-000197 [doi]
PST - epublish
SO  - BMJ Open Gastroenterol. 2018 Feb 16;5(1):e000197. doi: 
      10.1136/bmjgast-2017-000197. eCollection 2018.