Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial.
- Author:
Hyuk YOON
1
;
Dong Ho LEE
;
Yong Hyun LEE
;
Ju Cheol JEONG
;
Soo Teik LEE
;
Myung Gyu CHOI
;
Seong Woo JEON
;
Ki Nam SHIM
;
Gwang Ho BAIK
;
Jae Gyu KIM
;
Jeong Seop MOON
;
In Kyung SUNG
;
Sang Kil LEE
;
Poong Lyul RHEE
;
Hwoon Yong JUNG
;
Bong Eun LEE
;
Hyun Soo KIM
;
Sang Gyun KIM
;
Kee Myung LEE
;
Jae Kyu SEONG
;
Jin Seok JANG
;
Jong Jae PARK
Author Information
- Publication Type:Original Article
- Keywords: Mosapride; Functional dyspepsia; Compliance; Efficacy; Randomized clinical trial
- MeSH: Compliance; Dyspepsia*; Humans
- From:Gut and Liver 2018;12(5):516-522
- CountryRepublic of Korea
- Language:English
- Abstract: BACKGROUND/AIMS: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). METHODS: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. RESULTS: A total of 138 patients were enrolled (female, 73.9%; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%±4.52% vs 96.85%±6.05%, p=0.870). Changes in GIS scores were 9.69±6.44 and 10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, 1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups. CONCLUSIONS: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.
