Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 심기남 | * |
dc.date.accessioned | 2018-11-21T16:30:16Z | - |
dc.date.available | 2018-11-21T16:30:16Z | - |
dc.date.issued | 2018 | * |
dc.identifier.issn | 1976-2283 | * |
dc.identifier.issn | 2005-1212 | * |
dc.identifier.other | OAK-23043 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/246693 | - |
dc.description.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 end-point 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 UI05MSP015CT (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. | * |
dc.language | English | * |
dc.publisher | EDITORIAL OFFICE GUT & | * |
dc.publisher | LIVER | * |
dc.subject | Mosapride | * |
dc.subject | Functional dyspepsia | * |
dc.subject | Compliance | * |
dc.subject | Efficacy | * |
dc.subject | Randomized clinical trial | * |
dc.title | Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial | * |
dc.type | Article | * |
dc.relation.issue | 5 | * |
dc.relation.volume | 12 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.index | KCI | * |
dc.relation.startpage | 516 | * |
dc.relation.lastpage | 522 | * |
dc.relation.journaltitle | GUT AND LIVER | * |
dc.identifier.doi | 10.5009/gnl17416 | * |
dc.identifier.wosid | WOS:000450034600006 | * |
dc.identifier.scopusid | 2-s2.0-85053357801 | * |
dc.author.google | Yoon, Hyuk | * |
dc.author.google | Lee, Dong Ho | * |
dc.author.google | Lee, Yong-Hyun | * |
dc.author.google | Jeong, Ju-Cheol | * |
dc.author.google | Lee, Soo Teik | * |
dc.author.google | Choi, Myung-Gyu | * |
dc.author.google | Jeon, Seong Woo | * |
dc.author.google | Shim, Ki-Nam | * |
dc.author.google | Baik, Gwang Ho | * |
dc.author.google | Kim, Jae Gyu | * |
dc.author.google | Moon, Jeong Seop | * |
dc.author.google | Sung, In-Kyung | * |
dc.author.google | Lee, Sang Kil | * |
dc.author.google | Rhee, Poong-Lyul | * |
dc.author.google | Jung, Hwoon-Yong | * |
dc.author.google | Lee, Bong Eun | * |
dc.author.google | Kim, Hyun Soo | * |
dc.author.google | Kim, Sang Gyun | * |
dc.author.google | Lee, Kee Myung | * |
dc.author.google | Seong, Jae Kyu | * |
dc.author.google | Jang, Jin Seok | * |
dc.author.google | Park, Jong-Jae | * |
dc.contributor.scopusid | 심기남(13604838300) | * |
dc.date.modifydate | 20240118163912 | * |