Randomized, controlled, multi-center trial: Comparing the safety and efficacy of DA-9701 and itopride hydrochloride in patients with functional dyspepsia

Myung Gyu Choi, Poong Lyul Rhee, Hyojin Park, Oh Young Lee, Kwang Jae Lee, Suck Chei Choi, Sang Young Seol, Hoon-Jai Chun, Jong Sun Rew, Dong Ho Lee, Geun Am Song, Hwoon Yong Jung, Hyung Yong Jeong, In Kyung Sung, Joon Seong Lee, Soo Teik Lee, Sung Kook Kim, Yong Woon Shin

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background/Aims 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 dyspeptic 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 comparable safety.

Original languageEnglish
Pages (from-to)414-422
Number of pages9
JournalJournal of Neurogastroenterology and Motility
Volume21
Issue number3
DOIs
Publication statusPublished - 2015 Jan 1

    Fingerprint

Keywords

  • Clinical trial
  • DA-9701
  • Functional dyspepsia
  • Itopride

ASJC Scopus subject areas

  • Clinical Neurology
  • Gastroenterology

Cite this

Choi, M. G., Rhee, P. L., Park, H., Lee, O. Y., Lee, K. J., Choi, S. C., Seol, S. Y., Chun, H-J., Rew, J. S., Lee, D. H., Song, G. A., Jung, H. Y., Jeong, H. Y., Sung, I. K., Lee, J. S., Lee, S. T., Kim, S. K., & Shin, Y. W. (2015). Randomized, controlled, multi-center trial: Comparing the safety and efficacy of DA-9701 and itopride hydrochloride in patients with functional dyspepsia. Journal of Neurogastroenterology and Motility, 21(3), 414-422. https://doi.org/10.5056/jnm14117