Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia.
- Author:
Myung Gyu CHOI
1
;
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
Author Information
- Publication Type:Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords: Clinical trial; DA-9701; Functional dyspepsia; Itopride
- MeSH: Corydalis; Dyspepsia*; Humans; Quality of Life; Surveys and Questionnaires; Semen
- From:Journal of Neurogastroenterology and Motility 2015;21(3):414-422
- CountryRepublic of Korea
- Language:English
- 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.
