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J Neurogastroenterol Motil. 2015 Jul 30;21(3):414-22. doi: 10.5056/jnm14117.

Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.

Author information

1
Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea.
2
Sungkyunkwan University School of Medicine, Seoul, Korea.
3
Yonsei University College of Medicine, Seoul, Korea.
4
Hanyang University College of Medicine, Seoul, Korea.
5
Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea.
6
Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
7
Inje University College of Medicine, Busan, Korea.
8
Korea University College of Medicine, Seoul, Korea.
9
Chonnam National University College of Medicine, Gwangju, Korea.
10
Seoul National University College of Medicine, Seoul, Korea.
11
Pusan National University College of Medicine, Busan, Korea.
12
University of Ulsan College of Medicine, Seoul, Korea.
13
Chungnam National University College of Medicine, Daejeon, Korea.
14
Konkuk University College of Medicine, Seoul, Korea.
15
Soonchunhyang University College of Medicine, Seoul, Korea.
16
Chonbuk National University College of Medicine, Jeonju, Jeollabuk-do, Korea.
17
Kyungpook National University College of Medicine, Daegu, Korea.
18
Inha University College of Medicine, Incheon, Korea.

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 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.

KEYWORDS:

Clinical trial; DA-9701; Functional dyspepsia; Itopride

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