title: Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.
abstract: OBJECTIVE
  Therapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients.
  
  
  METHODS
  Patients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspep-tic symptoms and the overall treatment effect. Impact on patients' quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire.
  
  
  RESULTS
  We randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as ≥ 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable.
  
  
  CONCLUSIONS
  DA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with com-parable safety.
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Myung-Gyu
authors.identifier: http://orcid.org/0000-0003-4083-5187
authors.initials: MG
authors.lastname: Choi
authors.affiliation: Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Poong-Lyul
authors.initials: PL
authors.lastname: Rhee
authors.affiliation: Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hyojin
authors.initials: H
authors.lastname: Park
authors.affiliation: Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Oh Young
authors.initials: OY
authors.lastname: Lee
authors.affiliation: Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea.
authors.forename: Kwang Jae
authors.initials: KJ
authors.lastname: Lee
authors.affiliation: Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
authors.forename: Suck Chei
authors.initials: SC
authors.lastname: Choi
authors.affiliation: Inje University College of Medicine, Busan, Korea.
authors.forename: Sang Young
authors.initials: SY
authors.lastname: Seol
authors.affiliation: Korea University College of Medicine, Seoul, Korea.
authors.forename: Hoon Jai
authors.initials: HJ
authors.lastname: Chun
authors.affiliation: Chonnam National University College of Medicine, Gwangju, Korea.
authors.forename: Jong-Sun
authors.initials: JS
authors.lastname: Rew
authors.affiliation: Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Pusan National University College of Medicine, Busan, Korea.
authors.forename: Geun Am
authors.initials: GA
authors.lastname: Song
authors.affiliation: University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Hwoon Yong
authors.initials: HY
authors.lastname: Jung
authors.affiliation: Chungnam National University College of Medicine, Daejeon, Korea.
authors.forename: Hyung Yong
authors.initials: HY
authors.lastname: Jeong
authors.affiliation: Konkuk University College of Medicine, Seoul, Korea.
authors.forename: In Kyung
authors.initials: IK
authors.lastname: Sung
authors.affiliation: Soonchunhyang University College of Medicine, Seoul, Korea.
authors.forename: Joon Seong
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Chonbuk National University College of Medicine, Jeonju, Jeollabuk-do, Korea.
authors.forename: Soo Teik
authors.initials: ST
authors.lastname: Lee
authors.affiliation: Kyungpook National University College of Medicine, Daegu, Korea.
authors.forename: Sung Kook
authors.initials: SK
authors.lastname: Kim
authors.affiliation: Inha University College of Medicine, Incheon, Korea.
authors.forename: Yong Woon
authors.initials: YW
authors.lastname: Shin
keywords: Clinical trial; DA-9701; Functional dyspepsia; Itopride