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Original article
Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study
  1. Yuji Mizokami1,
  2. Kazunori Oda2,
  3. Nobuo Funao2,
  4. Akira Nishimura2,
  5. Satoshi Soen3,
  6. Takashi Kawai4,
  7. Kiyoshi Ashida5,
  8. Kentaro Sugano6
  1. 1 Endoscopic Center, University of Tsukuba Hospital, Tsukuba, Japan
  2. 2 Takeda Development Center, Takeda Pharmaceutical Company Ltd, Osaka, Japan
  3. 3 Department of Orthopaedic Surgery and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan
  4. 4 Endoscopy Center, Tokyo Medical University Hospital, Tokyo, Japan
  5. 5 Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan
  6. 6 Department of Medicine, Jichi Medical University, Tochigi, Japan
  1. Correspondence to Professor Yuji Mizokami, Endoscopic Center, University of Tsukuba Hospital, Tsukuba, Ibaraki 305-8576, Japan; yuji-mizokami{at}md.tsukuba.ac.jp

Footnotes

  • Contributors YM and KA were consultants for the clinical endpoint committee members for this study. SS was the medical adviser and TK was the medical expert for the study. KO and AN were responsible for clinical/scientific aspects of the study. NF was responsible for statistical analysis. Writing assistance was provided by content Ed Net and by Tania Dickson, PhD and Rebecca Lew, PhD, CMPP of ProScribe, Envision Pharma Group. KS was the coordinating investigator of this study.

  • Funding The study and writing assistance were funded by Takeda pharmaceutical company.

  • Competing interests YM has served as a consultant for, received grant and honorarium from Takeda Pharmaceutical Company. KO, NF and AN are employees of Takeda Pharmaceutical Company. SS has served as a consultant for and received a grant, honorarium and travel fee from Takeda Pharmaceutical Company. TK, KA and KS have served as a consultant and received a grant and honorarium from Takeda Pharmaceutical Company.

  • Patient consent Obtained.

  • Ethics approval This study is conducted in accordance with the standards of good clinical practice and incompliance with the declaration of Helsinki 2013 and local regulations, and has been submitted and approved by the institutional review boards of the study facilities.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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Footnotes

  • Contributors YM and KA were consultants for the clinical endpoint committee members for this study. SS was the medical adviser and TK was the medical expert for the study. KO and AN were responsible for clinical/scientific aspects of the study. NF was responsible for statistical analysis. Writing assistance was provided by content Ed Net and by Tania Dickson, PhD and Rebecca Lew, PhD, CMPP of ProScribe, Envision Pharma Group. KS was the coordinating investigator of this study.

  • Funding The study and writing assistance were funded by Takeda pharmaceutical company.

  • Competing interests YM has served as a consultant for, received grant and honorarium from Takeda Pharmaceutical Company. KO, NF and AN are employees of Takeda Pharmaceutical Company. SS has served as a consultant for and received a grant, honorarium and travel fee from Takeda Pharmaceutical Company. TK, KA and KS have served as a consultant and received a grant and honorarium from Takeda Pharmaceutical Company.

  • Patient consent Obtained.

  • Ethics approval This study is conducted in accordance with the standards of good clinical practice and incompliance with the declaration of Helsinki 2013 and local regulations, and has been submitted and approved by the institutional review boards of the study facilities.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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