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  • 1. Aims and Scope

    Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut atnd Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology. +MORE

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    Yong Chan Lee Professor of Medicine
    Director, Gastrointestinal Research Laboratory
    Veterans Affairs Medical Center, Univ. California San Francisco
    San Francisco, USA

    Deputy Editor

    Deputy Editor
    Jong Pil Im Seoul National University College of Medicine, Seoul, Korea
    Robert S. Bresalier University of Texas M. D. Anderson Cancer Center, Houston, USA
    Steven H. Itzkowitz Mount Sinai Medical Center, NY, USA
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    All papers submitted to Gut and Liver are reviewed by the editorial team before being sent out for an external peer review to rule out papers that have low priority, insufficient originality, scientific flaws, or the absence of a message of importance to the readers of the Journal. A decision about these papers will usually be made within two or three weeks.
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Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial

Ja Seol Koo1 , Jeong-Sik Byeon2 , Bo-In Lee3 , Sung-Ae Jung4 , Tae Il Kim5 , and Yoon Tae Jeen6

1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ansan Hospital, Korea University College of Medicine, Ansan, 2Department of Gastroenterology, University of Ulsan College of Medicine, 3Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, 4Department of Internal Medicine, Ewha Womans University College of Medicine, 5Department of Internal Medicine, Yonsei University College of Medicine, and 6Division of Gastroenterology and Hepatology, Department of Internal Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Korea

Correspondence to:Yoon Tae Jeen
ORCID https://orcid.org/0000-0003-0220-3816
E-mail ytjeen@korea.ac.kr

Received: February 25, 2021; Revised: May 7, 2021; Accepted: June 14, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Gut and Liver

Published online November 23, 2021

Copyright © Gut and Liver.

Abstract

Background/Aims: Polyethylene glycol (PEG)-based bowel preparations are effective cleansing 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 protocol 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.

Keywords: Colonoscopy, Cathartics, Polyethylene glycols, Ascorbic acid, Safety


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Gut and Liver

Published online November 23, 2021

Copyright © Gut and Liver.

Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial

Ja Seol Koo1 , Jeong-Sik Byeon2 , Bo-In Lee3 , Sung-Ae Jung4 , Tae Il Kim5 , and Yoon Tae Jeen6

1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ansan Hospital, Korea University College of Medicine, Ansan, 2Department of Gastroenterology, University of Ulsan College of Medicine, 3Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, 4Department of Internal Medicine, Ewha Womans University College of Medicine, 5Department of Internal Medicine, Yonsei University College of Medicine, and 6Division of Gastroenterology and Hepatology, Department of Internal Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Korea

Correspondence to:Yoon Tae Jeen
ORCID https://orcid.org/0000-0003-0220-3816
E-mail ytjeen@korea.ac.kr

Received: February 25, 2021; Revised: May 7, 2021; Accepted: June 14, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background/Aims: Polyethylene glycol (PEG)-based bowel preparations are effective cleansing 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 protocol 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.

Keywords: Colonoscopy, Cathartics, Polyethylene glycols, Ascorbic acid, Safety

Gut and Liver

Vol.15 No.6
November, 2021

pISSN 1976-2283
eISSN 2005-1212

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