Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial
DC Field | Value | Language |
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dc.contributor.author | Koo, Ja Seol | - |
dc.contributor.author | Byeon, Jeong-Sik | - |
dc.contributor.author | Lee, Bo-In | - |
dc.contributor.author | Jung, Sung-Ae | - |
dc.contributor.author | Kim, Tae Il | - |
dc.contributor.author | Jeen, Yoon Tae | - |
dc.date.accessioned | 2022-06-12T10:41:19Z | - |
dc.date.available | 2022-06-12T10:41:19Z | - |
dc.date.created | 2022-06-10 | - |
dc.date.issued | 2022 | - |
dc.identifier.issn | 1976-2283 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/142129 | - |
dc.description.abstract | Background/Aims: Polyethylene glycol (PEG)-based bowel preparations are effective cleans-ing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG. Methods: Patients undergoing colonoscopy were randomized (1:1:1) to receive TJP-008 as 1-day split dose (TJP-008-1) or 2-day split dose (TJP-008-2) regimen or to receive 2LPEG as a 2-day split dose regimen. Cleansing efficacy was evaluated using the Harefield Cleansing Scale. The primary endpoint was overall bowel cleansing success. Full analysis set (FAS) and per pro-tocol set (PPS) analyses were performed. Results: Of the 314 screened patients, efficacy was assessed in the following patient numbers (FAS/PPS): total (293/285), TJP-008-1 (98/94), TJP-008-2 (97/95), and 2LPEG (98/96). FAS revealed noninferiority between TJP-008 and 2LPEG with regard to overall success (TJP-008-2, 99.0%; TJP-008-1, 95.9%; 2LPEG, 94.9%; p=0.100 and p=0.733, respectively). PPS also showed noninferiority (p=0.721 and p=0.211, respectively). However, the PPS analyses showed a higher bowel cleansing score for TJP-008-2 for high-quality cleansing in the right colon (TJP-008-2 83.2% vs 2LPEG 62.5%; p=0.005). Conclusions: TJP-008 is a new low-volume cleansing agent with a colon cleansing efficacy comparable to that of standard 2LPEG that exhibits significant safety and tolerability. (Gut Liver, Published online November 23, 2021) | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | EDITORIAL OFFICE GUT & LIVER | - |
dc.subject | BOWEL PREPARATION | - |
dc.subject | COLORECTAL-CANCER | - |
dc.subject | QUALITY | - |
dc.subject | COLONOSCOPY | - |
dc.subject | RECOMMENDATIONS | - |
dc.subject | SOCIETY | - |
dc.subject | RISK | - |
dc.title | Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial | - |
dc.title.alternative | Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Koo, Ja Seol | - |
dc.identifier.doi | 10.5009/gnl210092 | - |
dc.identifier.scopusid | 2-s2.0-85126830528 | - |
dc.identifier.wosid | 000722847600001 | - |
dc.identifier.bibliographicCitation | GUT AND LIVER, v.16, no.2, pp.259 - 268 | - |
dc.relation.isPartOf | GUT AND LIVER | - |
dc.citation.title | GUT AND LIVER | - |
dc.citation.volume | 16 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 259 | - |
dc.citation.endPage | 268 | - |
dc.type.rims | ART | - |
dc.type.docType | Article; Early Access | - |
dc.identifier.kciid | ART002820901 | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | COLORECTAL-CANCER | - |
dc.subject.keywordPlus | QUALITY | - |
dc.subject.keywordPlus | COLONOSCOPY | - |
dc.subject.keywordPlus | RECOMMENDATIONS | - |
dc.subject.keywordPlus | SOCIETY | - |
dc.subject.keywordPlus | RISK | - |
dc.subject.keywordPlus | BOWEL PREPARATION | - |
dc.subject.keywordAuthor | Colonoscopy | - |
dc.subject.keywordAuthor | Cathartics | - |
dc.subject.keywordAuthor | Polyethylene glycols | - |
dc.subject.keywordAuthor | Ascorbic acid | - |
dc.subject.keywordAuthor | Safety | - |
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