Effects of the New Prokinetic Agent DA-9701 Formulated With Corydalis Tuber and Pharbitis Seed in Patients With Minimal Change Esophagitis: A Bicenter, Randomized, Double Blind, Placebo-controlled Study.
- Author:
Chan Hyuk PARK
1
;
Hyun Soo KIM
;
Sang Kil LEE
Author Information
1. Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Institute of Gastroenterology, Brain Korea 21 PLUS project for Medical Science, Yonsei University College of Medicine, Seoul, Korea. sklee@yuhs.ac
- Publication Type:Randomized Controlled Trial ; Original Article
- Keywords:
DA-9701;
Minimal change esophagitis;
Motilitone;
Non-erosive reflux disease
- MeSH:
Corydalis*;
Dyspepsia;
Esophagitis*;
Humans;
Quality of Life
- From:Journal of Neurogastroenterology and Motility
2014;20(3):338-346
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: DA-9701 (Motilitone) is a new prokinetic agent formulated with Corydalis Tuber and Pharbitis Seed. We assessed the efficacy of DA-9701 in symptomatic patients with minimal change esophagitis. METHODS: Patients with minimal change esophagitis presenting with reflux or dyspeptic symptoms were randomly assigned to receive either DA-9701 30 mg or placebo t.i.d. (means 3 times a day). After 4 weeks of treatment, the primary efficacy end point determined by changes of the Nepean dyspepsia index questionnaire-Korean version (NDI-K) symptom scores, was analyzed. RESULTS: Forty-two and 39 patients were assigned to the treatment and control groups, respectively. After 4 weeks, NDI-K symptom scores were reduced from 35.4 to 13.5 (P < 0.001) and from 43.0 to 27.7 (P < 0.001) in the treatment and the control groups, respectively. However, changes in the symptom scores did not differ between the 2 groups (P = 0.741). Although the quality of life scores were significantly improved after 4 weeks in both groups, changes in the quality of life score between the baseline value and that at 4 weeks did not differ between the 2 groups. The reflux symptom score was significantly improved in the treatment group compared to the placebo group in patients aged 65 years or older (P = 0.035). CONCLUSIONS: Although NDI-K symptom scores and quality of life scores were improved after 4 weeks of treatment compared with baseline values in patients with minimal change esophagitis, DA-9701 did not improve the symptom scores or quality of life scores compared with the placebo.
