PMID- 26811504
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160401
LR  - 20201001
IS  - 2093-0879 (Print)
IS  - 2093-0887 (Electronic)
IS  - 2093-0879 (Linking)
VI  - 22
IP  - 2
DP  - 2016 Apr 30
TI  - Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to 
      Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.
PG  - 254-63
LID - 10.5056/jnm15178 [doi]
AB  - BACKGROUND/AIMS: The effect of proton pump inhibitors (PPI) in Asian functional 
      dyspepsia (FD) patients has not been well established as in Westerncountries. 
      DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates 
      visceral hypersensitivity in vivo and in human studies. This study was conducted 
      to compare the efficacy of DA-9701 with a conventional PPI in mono or combination 
      therapy in patients with FD. METHODS: In this double-blind, randomized, 
      non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria 
      were allocated among3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg 
      pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. Theprimary efficacy 
      end-point was a global assessment of the patient binary response or response on a 
      5-Likert scale after 4 weeks. RESULTS: The global symptomatic improvement was 
      60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the 
      DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant 
      difference among 3 groups (P = 0.685). Symptomimprovement measured by binary 
      outcome was significantly achieved in each of the 3 groups, but not different 
      among groups.Patients in all treatment groups reported significant improvement in 
      the response rate and symptoms according to FD subtypes anddyspepsia-related 
      quality of life (P < 0.001), but there were no significant differences among the 
      3 groups. CONCLUSIONS: DA-9701 improves global and individual symptoms and 
      increases dyspepsia-specific quality of life in patients with FD. The efficacyof 
      DA-9701 monotherapy is comparable with pantoprazole and there is no additive 
      effect with combination of DA-9701 andpantoprazole in patients with FD.
FAU - Jung, Hye-Kyung
AU  - Jung HK
AD  - Department of Internal Medicine, Ewha Womans University School of Medicine, 
      Seoul, Korea.
FAU - Lee, Kwang Jae
AU  - Lee KJ
AD  - Department of Gastroenterology, Ajou University School of Medicine, Suwon, 
      Gyeonggi-do, Korea.
FAU - Choi, Myung-Gyu
AU  - Choi MG
AD  - Department of Internal Medicine, Catholic University College of Medicine, Seoul, 
      Korea.
FAU - Park, Hyojin
AU  - Park H
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Lee, Joon Seong
AU  - Lee JS
AD  - Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
FAU - Rhee, Poong-Lyul
AU  - Rhee PL
AD  - Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University 
      School of Medicine, Seoul, Korea.
FAU - Kim, Nayoung
AU  - Kim N
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seongnam, Gyeonggi-do, Korea.
FAU - Park, KyungSik
AU  - Park K
AD  - Department of Internal Medicine, Keimyung University College of Medicine, Daegu, 
      Korea.
FAU - Choi, Suck Chei
AU  - Choi SC
AD  - Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, 
      Jeollabuk-do, Korea.
FAU - Lee, Oh Young
AU  - Lee OY
AD  - Department of Internal Medicine, Hanyang University College of Medicine, Seoul, 
      Korea.
FAU - Huh, Kyu Chan
AU  - Huh KC
AD  - Department of Internal Medicine, Konyang University College of Medicine, Daejeon, 
      Korea.
FAU - Song, Geun Am
AU  - Song GA
AD  - Department of Internal Medicine, Pusan National University College of Medicine, 
      Busan, Korea.
FAU - Hong, Su Jin
AU  - Hong SJ
AD  - Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
FAU - Sohn, Chong Il
AU  - Sohn CI
AD  - Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan 
      University School of Medicine, Seoul, Korea.
FAU - Jung, Hwoon-Yong
AU  - Jung HY
AD  - Department of Internal Medicine, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea.
FAU - Lee, Yong Chan
AU  - Lee YC
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Rew, Jong Sun
AU  - Rew JS
AD  - Chonnam National University Medical School, Gwangju, Korea.
FAU - Jee, Sam Ryong
AU  - Jee SR
AD  - Department of Internal Medicine, Inje University College of Medicine, Busan, 
      Korea.
FAU - Kwon, Joong Goo
AU  - Kwon JG
AD  - Department of Internal Medicine, Catholic University of Daegu, School of 
      Medicine, Daegu, Korea.
LA  - eng
PT  - Journal Article
PL  - Korea (South)
TA  - J Neurogastroenterol Motil
JT  - Journal of neurogastroenterology and motility
JID - 101530189
PMC - PMC4819864
OTO - NOTNLM
OT  - DA-9701 (Motilitone)
OT  - Dyspepsia
OT  - Proton pump inhibitor
EDAT- 2016/01/27 06:00
MHDA- 2016/01/27 06:01
PMCR- 2016/04/01
CRDT- 2016/01/27 06:00
PHST- 2015/10/13 00:00 [received]
PHST- 2015/12/28 00:00 [revised]
PHST- 2016/01/17 00:00 [accepted]
PHST- 2016/01/27 06:00 [entrez]
PHST- 2016/01/27 06:00 [pubmed]
PHST- 2016/01/27 06:01 [medline]
PHST- 2016/04/01 00:00 [pmc-release]
AID - jnm15178 [pii]
AID - jnm-22-254 [pii]
AID - 10.5056/jnm15178 [doi]
PST - ppublish
SO  - J Neurogastroenterol Motil. 2016 Apr 30;22(2):254-63. doi: 10.5056/jnm15178.