Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial
DC Field | Value | Language |
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dc.contributor.author | Yoon, Hyuk | - |
dc.contributor.author | Lee, Dong Ho | - |
dc.contributor.author | Lee, Yong-Hyun | - |
dc.contributor.author | Jeong, Ju-Cheol | - |
dc.contributor.author | Lee, Soo Teik | - |
dc.contributor.author | Choi, Myung-Gyu | - |
dc.contributor.author | Jeon, Seong Woo | - |
dc.contributor.author | Shim, Ki-Nam | - |
dc.contributor.author | Baik, Gwang Ho | - |
dc.contributor.author | Kim, Jae Gyu | - |
dc.contributor.author | Moon, Jeong Seop | - |
dc.contributor.author | Sung, In-Kyung | - |
dc.contributor.author | Lee, Sang Kil | - |
dc.contributor.author | Rhee, Poong-Lyul | - |
dc.contributor.author | Jung, Hwoon-Yong | - |
dc.contributor.author | Lee, Bong Eun | - |
dc.contributor.author | Kim, Hyun Soo | - |
dc.contributor.author | Kim, Sang Gyun | - |
dc.contributor.author | Lee, Kee Myung | - |
dc.contributor.author | Seong, Jae Kyu | - |
dc.contributor.author | Jang, Jin Seok | - |
dc.contributor.author | Park, Jong-Jae | - |
dc.date.available | 2020-11-02T07:03:57Z | - |
dc.date.issued | 2018-09 | - |
dc.identifier.issn | 1976-2283 | - |
dc.identifier.issn | 2005-1212 | - |
dc.identifier.uri | https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/3196 | - |
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.format.extent | 7 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | EDITORIAL OFFICE GUT & LIVER | - |
dc.title | Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial | - |
dc.type | Article | - |
dc.publisher.location | 대한민국 | - |
dc.identifier.doi | 10.5009/gnl17416 | - |
dc.identifier.scopusid | 2-s2.0-85053357801 | - |
dc.identifier.wosid | 000450034600006 | - |
dc.identifier.bibliographicCitation | GUT AND LIVER, v.12, no.5, pp 516 - 522 | - |
dc.citation.title | GUT AND LIVER | - |
dc.citation.volume | 12 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 516 | - |
dc.citation.endPage | 522 | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002384251 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | GASTROINTESTINAL DISORDERS | - |
dc.subject.keywordPlus | HERBAL PREPARATION | - |
dc.subject.keywordPlus | MULTICENTER TRIAL | - |
dc.subject.keywordPlus | CONSENSUS REPORT | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | MOSAPRIDE | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordPlus | FAMOTIDINE | - |
dc.subject.keywordPlus | CISAPRIDE | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordAuthor | Mosapride | - |
dc.subject.keywordAuthor | Functional dyspepsia | - |
dc.subject.keywordAuthor | Compliance | - |
dc.subject.keywordAuthor | Efficacy | - |
dc.subject.keywordAuthor | Randomized clinical trial | - |
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