J Neurogastroenterol Motil.
2015 Jul;21(3):414-422. 10.5056/jnm14117.
Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia
- Choi MG
- Rhee PL
- Park H
- Lee OY
- Lee KJ
- Choi SC
- Seol SY
- Chun HJ
- Rew JS
- Lee DH
- Song GA
- Jung HY
- Jeong HY
- Sung IK
- Lee JS
- Lee ST
- Kim SK
- Shin YW
- Affiliations
-
- 1Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea. choim@catholic.ac.kr
- 2Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 3Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
- 5Department of Internal Medicine, Ajou University School of Medicine, Suwon, Gyeonggi-do, Korea.
- 6Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
- 7Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
- 8Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
- 9Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, Korea.
- 10Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
- 11Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea.
- 12Department of Internal Medicine, University of Ulsan College of Medicine, Seoul, Korea.
- 13Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
- 14Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.
- 15Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
- 16Department of Internal Medicine, Chonbuk National University College of Medicine, Jeonju, Jeollabuk-do, Korea.
- 17Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea.
- 18Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.
- KMID: 2433481
- DOI: http://doi.org/10.5056/jnm14117
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 > or = 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.
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