Hyo-Joon Yang1, Dong Il Park1, Soo-Kyung Park1, Chang Kyun Lee2, Hyo Jong Kim2, Shin Ju Oh2, Jung Rock Moon2, Beom Jae Lee3, Jin Sung Koh3, Hyun Soo Kim4, Seon-Young Park4, Dong Hyun Kim4, Jaeyoung Chun5, Eun Ae Kang5, Jung Kim5, Hosim Soh5, Chang Soo Eun6, You Sun Kim7, Yoon Tae Jeen8. 1. Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. 2. Center for Crohn's and Colitis, Department of Gastroenterology and Hepatology, Kyung Hee University School of Medicine, Seoul, Korea. 3. Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea. 4. Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea. 5. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. 6. Department of Internal Medicine, Hanyang University Guri Hospital, Gyeonggi-Do, Korea. 7. Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea. 8. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
Abstract
BACKGROUND AND AIM: PBK-1701TC is a novel sulfate tablet-based that contains 320 mg of simethicone and delivers 90% of the salt and water delivered by oral sulfate solution (OSS) preparation. This study evaluated the efficacy, safety, and tolerability of PBK-1701TC compared with OSS in bowel preparation for colonoscopy. METHODS: This randomized, multicenter, phase 3 non-inferiority trial included adults aged 19 years or older with a body mass index of 19-30 kg/m2 undergoing colonoscopy at five university hospitals in Korea. The primary efficacy endpoint was successful bowel-cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded central readers. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Tolerability was assessed via participant interview. RESULTS: Overall, 235 participants were randomized, and 224 were included in the per-protocol analysis (PBK, 112; OSS, 112). Successful bowel cleansing was achieved for 95.5% (107/112) in the PBK group, which was non-inferior to the OSS group (98.2%, 110/112) with a difference of -2.7% (one sided 97.5% confidence limit, -8.1%). The participants in the PBK group had fewer intraluminal bubbles (0.9% vs 81.3%, P < 0.001) and reported a lower incidence of nausea and vomiting, with better acceptance, taste, and willingness to repeat the regimen than those in the OSS group (all P < 0.05). CONCLUSION: The novel sulfate tablet, PBK-1701TC, was non-inferior to OSS with respect to bowel-cleansing efficacy and exhibited better safety and tolerability in adults undergoing colonoscopy.
RCT Entities:
BACKGROUND AND AIM: PBK-1701TC is a novel sulfate tablet-based that contains 320 mg of simethicone and delivers 90% of the salt and water delivered by oral sulfate solution (OSS) preparation. This study evaluated the efficacy, safety, and tolerability of PBK-1701TC compared with OSS in bowel preparation for colonoscopy. METHODS: This randomized, multicenter, phase 3 non-inferiority trial included adults aged 19 years or older with a body mass index of 19-30 kg/m2 undergoing colonoscopy at five university hospitals in Korea. The primary efficacy endpoint was successful bowel-cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded central readers. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Tolerability was assessed via participant interview. RESULTS: Overall, 235 participants were randomized, and 224 were included in the per-protocol analysis (PBK, 112; OSS, 112). Successful bowel cleansing was achieved for 95.5% (107/112) in the PBK group, which was non-inferior to the OSS group (98.2%, 110/112) with a difference of -2.7% (one sided 97.5% confidence limit, -8.1%). The participants in the PBK group had fewer intraluminal bubbles (0.9% vs 81.3%, P < 0.001) and reported a lower incidence of nausea and vomiting, with better acceptance, taste, and willingness to repeat the regimen than those in the OSS group (all P < 0.05). CONCLUSION: The novel sulfate tablet, PBK-1701TC, was non-inferior to OSS with respect to bowel-cleansing efficacy and exhibited better safety and tolerability in adults undergoing colonoscopy.
Authors: Dale R Bachwich; James D Lewis; Vera O Kowal; Brian C Jacobson; Audrey H Calderwood; Michael L Kochman Journal: Clin Transl Gastroenterol Date: 2020-12 Impact factor: 4.396
Authors: Jae Hyun Kim; Yong Eun Park; Tae Oh Kim; Jongha Park; Gyu Man Oh; Won Moon; Seun Ja Park Journal: Medicine (Baltimore) Date: 2022-07-08 Impact factor: 1.817