Evaluation of the efficacy and safety of DA-9601 versus its new formulation, DA-5204, in patients with gastritis: Phase III, randomized, double-blind, non-inferiority study

Yoon Jin Choi, Dong Ho Lee, Myung Gyu Choi, Sung Joon Lee, Sung Kook Kim, Geun Am Song, Poong Lyul Rhee, Hwoon Yong Jung, Dae Hwan Kang, Yong Chan Lee, Si Hyung Lee, Suck Chei Choi, Ki Nam Shim, Sang Yong Seol, Jeong Seop Moon, Yong Woon Shin, Hyun Soo Kim, Soo Teik Lee, Jin Woong Cho, Eun Kwang ChoiOh Young Lee, Jin Seok Jang

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA- 9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA- 9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).

Original languageEnglish
Pages (from-to)1807-1813
Number of pages7
JournalJournal of Korean medical science
Volume32
Issue number11
DOIs
Publication statusPublished - 2017 Nov 1

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Gastritis
Safety
Stomach
Drug-Related Side Effects and Adverse Reactions
DA 9601
Korea
Endoscopy
Randomized Controlled Trials
Confidence Intervals
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Choi, Yoon Jin ; Lee, Dong Ho ; Choi, Myung Gyu ; Lee, Sung Joon ; Kim, Sung Kook ; Song, Geun Am ; Rhee, Poong Lyul ; Jung, Hwoon Yong ; Kang, Dae Hwan ; Lee, Yong Chan ; Lee, Si Hyung ; Choi, Suck Chei ; Shim, Ki Nam ; Seol, Sang Yong ; Moon, Jeong Seop ; Shin, Yong Woon ; Kim, Hyun Soo ; Lee, Soo Teik ; Cho, Jin Woong ; Choi, Eun Kwang ; Lee, Oh Young ; Jang, Jin Seok. / Evaluation of the efficacy and safety of DA-9601 versus its new formulation, DA-5204, in patients with gastritis : Phase III, randomized, double-blind, non-inferiority study. In: Journal of Korean medical science. 2017 ; Vol. 32, No. 11. pp. 1807-1813.
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abstract = "This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1{\%} (88/209) and 42.5{\%} (90/212), respectively. The difference between the groups was -0.4{\%} (95{\%} confidence interval, -9.8{\%} to 9.1{\%}), which was above the non-inferiority margin of -14{\%}. The cure rate of gastric erosion in both groups was 37.3{\%}. The improvement rates of GI symptoms with DA-5204 and DA- 9601 were 40.4{\%} and 40.8{\%}, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4{\%}) patients in the DA-5204 group and 19 (8.8{\%}) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA- 9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).",
author = "Choi, {Yoon Jin} and Lee, {Dong Ho} and Choi, {Myung Gyu} and Lee, {Sung Joon} and Kim, {Sung Kook} and Song, {Geun Am} and Rhee, {Poong Lyul} and Jung, {Hwoon Yong} and Kang, {Dae Hwan} and Lee, {Yong Chan} and Lee, {Si Hyung} and Choi, {Suck Chei} and Shim, {Ki Nam} and Seol, {Sang Yong} and Moon, {Jeong Seop} and Shin, {Yong Woon} and Kim, {Hyun Soo} and Lee, {Soo Teik} and Cho, {Jin Woong} and Choi, {Eun Kwang} and Lee, {Oh Young} and Jang, {Jin Seok}",
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Choi, YJ, Lee, DH, Choi, MG, Lee, SJ, Kim, SK, Song, GA, Rhee, PL, Jung, HY, Kang, DH, Lee, YC, Lee, SH, Choi, SC, Shim, KN, Seol, SY, Moon, JS, Shin, YW, Kim, HS, Lee, ST, Cho, JW, Choi, EK, Lee, OY & Jang, JS 2017, 'Evaluation of the efficacy and safety of DA-9601 versus its new formulation, DA-5204, in patients with gastritis: Phase III, randomized, double-blind, non-inferiority study', Journal of Korean medical science, vol. 32, no. 11, pp. 1807-1813. https://doi.org/10.3346/jkms.2017.32.11.1807

Evaluation of the efficacy and safety of DA-9601 versus its new formulation, DA-5204, in patients with gastritis : Phase III, randomized, double-blind, non-inferiority study. / Choi, Yoon Jin; Lee, Dong Ho; Choi, Myung Gyu; Lee, Sung Joon; Kim, Sung Kook; Song, Geun Am; Rhee, Poong Lyul; Jung, Hwoon Yong; Kang, Dae Hwan; Lee, Yong Chan; Lee, Si Hyung; Choi, Suck Chei; Shim, Ki Nam; Seol, Sang Yong; Moon, Jeong Seop; Shin, Yong Woon; Kim, Hyun Soo; Lee, Soo Teik; Cho, Jin Woong; Choi, Eun Kwang; Lee, Oh Young; Jang, Jin Seok.

In: Journal of Korean medical science, Vol. 32, No. 11, 01.11.2017, p. 1807-1813.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Evaluation of the efficacy and safety of DA-9601 versus its new formulation, DA-5204, in patients with gastritis

T2 - Phase III, randomized, double-blind, non-inferiority study

AU - Choi, Yoon Jin

AU - Lee, Dong Ho

AU - Choi, Myung Gyu

AU - Lee, Sung Joon

AU - Kim, Sung Kook

AU - Song, Geun Am

AU - Rhee, Poong Lyul

AU - Jung, Hwoon Yong

AU - Kang, Dae Hwan

AU - Lee, Yong Chan

AU - Lee, Si Hyung

AU - Choi, Suck Chei

AU - Shim, Ki Nam

AU - Seol, Sang Yong

AU - Moon, Jeong Seop

AU - Shin, Yong Woon

AU - Kim, Hyun Soo

AU - Lee, Soo Teik

AU - Cho, Jin Woong

AU - Choi, Eun Kwang

AU - Lee, Oh Young

AU - Jang, Jin Seok

PY - 2017/11/1

Y1 - 2017/11/1

N2 - This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA- 9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA- 9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).

AB - This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA- 9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA- 9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).

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