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
© 2023. Japanese Society of Gastroenterology..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:58 |
|---|---|
| Enthalten in: |
Journal of gastroenterology - 58(2023), 11 vom: 05. Nov., Seite 1114-1123 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Jeon, Seong Ran [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Bowel preparation |
|---|
| Anmerkungen: |
Date Revised 21.10.2023 published: Print-Electronic ClinicalTrials.gov: NCT05670470 Citation Status Publisher |
|---|
| doi: |
10.1007/s00535-023-02023-5 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM360423639 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM360423639 | ||
| 003 | DE-627 | ||
| 005 | 20231226083001.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s00535-023-02023-5 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1201.xml |
| 035 | |a (DE-627)NLM360423639 | ||
| 035 | |a (NLM)37542674 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Jeon, Seong Ran |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Comparison of a novel mini-oral sulfate tablet and the conventional oral sulfate tablet in bowel preparation for colonoscopy |b a prospective, randomized, investigator-blinded, multicenter, non-inferior, phase 3 trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 21.10.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05670470 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2023. Japanese Society of Gastroenterology. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Bowel preparation | |
| 650 | 4 | |a Colonoscopy | |
| 650 | 4 | |a Efficacy | |
| 650 | 4 | |a Mini-oral sulfate tablet | |
| 650 | 4 | |a Oral sulfate tablet | |
| 700 | 1 | |a Park, Soo-Kyung |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Dong-Hoon |e verfasserin |4 aut | |
| 700 | 1 | |a Cha, Jae Myung |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of gastroenterology |d 1994 |g 58(2023), 11 vom: 05. Nov., Seite 1114-1123 |w (DE-627)NLM074913832 |x 1435-5922 |7 nnns |
| 773 | 1 | 8 | |g volume:58 |g year:2023 |g number:11 |g day:05 |g month:11 |g pages:1114-1123 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s00535-023-02023-5 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 58 |j 2023 |e 11 |b 05 |c 11 |h 1114-1123 | ||