PMID- 37542674
OWN - NLM
STAT- Publisher
LR  - 20231021
IS  - 1435-5922 (Electronic)
IS  - 0944-1174 (Linking)
VI  - 58
IP  - 11
DP  - 2023 Nov
TI  - Comparison of a novel mini-oral sulfate tablet and the conventional oral sulfate 
      tablet in bowel preparation for colonoscopy: a prospective, randomized, 
      investigator-blinded, multicenter, non-inferior, phase 3 trial.
PG  - 1114-1123
LID - 10.1007/s00535-023-02023-5 [doi]
AB  - BACKGROUND AND AIMS: The use of conventional oral sulfate tablets (OSTs) has 
      gained popularity; nonetheless, they may be not only inconvenient to swallow but 
      also difficult to dissolve. A novel mini-OST has recently been developed to 
      enhance compliance with conventional OST use. This study aimed to compare the 
      efficacy, tolerability, and safety between mini-OST and conventional OST. 
      METHODS: This was a prospective, randomized, investigator-blinded, multicenter, 
      and non-inferior phase 3 trial conducted between September 2022 and December 
      2022. The efficacy, safety, and tolerability were compared between mini-OST and 
      conventional OST. RESULTS: Exactly 83 patients were evaluated based on a full 
      analysis set (FAS), whereas 82 patients were evaluated as a per-protocol set 
      (PPS). With respect to the efficacy of preparation, successful and high-quality 
      preparation was excellent in the mini-OST and conventional OST groups on both FAS 
      and PPS analyses, without significant differences between the two groups. On the 
      FAS analysis, the satisfaction and tolerability scores were high in both groups, 
      without significant differences. The first bowel movement after taking the 
      investigational product occurred 30 min earlier in the mini-OST group than in the 
      OST group. Mild, moderate, and severe adverse events (AEs) were comparable 
      between the two groups; however, any AEs were more common in the mini-OST group 
      than in the conventional OST group overall. CONCLUSIONS: Compared with 
      conventional OST, the novel mini-OST preparation showed similar efficacy, 
      tolerability, and safety, including mild eight solicited AEs and 
      moderate-to-severe AEs. Clinical trial registration NCT05670470.
CI  - (c) 2023. Japanese Society of Gastroenterology.
FAU - Jeon, Seong Ran
AU  - Jeon SR
AD  - Institute of Digestive Research, Digestive Disease Center, Soonchunhyang 
      University College of Medicine, Seoul, Korea.
FAU - Park, Soo-Kyung
AU  - Park SK
AD  - Department of Gastroenterology, Kangbuk Samsung Hospital, Sungkyunkwan University 
      School of Medicine, Seoul, Korea.
FAU - Yang, Dong-Hoon
AU  - Yang DH
AD  - Department of Gastroenterology, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea.
FAU - Cha, Jae Myung
AU  - Cha JM
AD  - Division of Gastroenterology, Department of Internal Medicine, Kyung Hee 
      University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, 
      Korea. drcha@khu.ac.kr.
AD  - Division of Gastroenterology, Department of Internal Medicine, Kyung Hee 
      University Hospital at Gang Dong, Kyung Hee University School of Medicine, 892 
      Dongnam-Ro, Gangdong-Gu, Seoul, 05278, Korea. drcha@khu.ac.kr.
LA  - eng
SI  - ClinicalTrials.gov/NCT05670470
PT  - Journal Article
DEP - 20230805
PL  - Japan
TA  - J Gastroenterol
JT  - Journal of gastroenterology
JID - 9430794
SB  - IM
OTO - NOTNLM
OT  - Bowel preparation
OT  - Colonoscopy
OT  - Efficacy
OT  - Mini-oral sulfate tablet
OT  - Oral sulfate tablet
EDAT- 2023/08/06 05:41
MHDA- 2023/08/06 05:41
CRDT- 2023/08/05 11:14
PHST- 2023/03/27 00:00 [received]
PHST- 2023/07/08 00:00 [accepted]
PHST- 2023/08/06 05:41 [pubmed]
PHST- 2023/08/06 05:41 [medline]
PHST- 2023/08/05 11:14 [entrez]
AID - 10.1007/s00535-023-02023-5 [pii]
AID - 10.1007/s00535-023-02023-5 [doi]
PST - ppublish
SO  - J Gastroenterol. 2023 Nov;58(11):1114-1123. doi: 10.1007/s00535-023-02023-5. Epub 
      2023 Aug 5.