Cited 6 times in
Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial
DC Field | Value | Language |
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dc.contributor.author | 이상길 | - |
dc.date.accessioned | 2018-10-22T13:18:51Z | - |
dc.date.available | 2018-10-22T13:18:51Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 1976-2283 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/163745 | - |
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 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Editorial Office of Gut and Liver | - |
dc.relation.isPartOf | GUT AND LIVER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Hyuk Yoon | - |
dc.contributor.googleauthor | Dong Ho Lee | - |
dc.contributor.googleauthor | Yong-Hyun Lee | - |
dc.contributor.googleauthor | Ju-Cheol Jeong | - |
dc.contributor.googleauthor | Soo Teik Lee | - |
dc.contributor.googleauthor | Myung-Gyu Choi | - |
dc.contributor.googleauthor | Seong Woo Jeon | - |
dc.contributor.googleauthor | Ki-Nam Shim | - |
dc.contributor.googleauthor | Gwang Ho Baik | - |
dc.contributor.googleauthor | Jae Gyu Kim | - |
dc.contributor.googleauthor | Jeong Seop Moon | - |
dc.contributor.googleauthor | In-Kyung Sung | - |
dc.contributor.googleauthor | Sang Kil Lee | - |
dc.contributor.googleauthor | Poong-Lyul Rhee | - |
dc.contributor.googleauthor | Hwoon-Yong Jung | - |
dc.contributor.googleauthor | Bong Eun Lee | - |
dc.contributor.googleauthor | Hyun Soo Kim | - |
dc.contributor.googleauthor | Sang Gyun Kim | - |
dc.contributor.googleauthor | Kee Myung Lee | - |
dc.contributor.googleauthor | Jae Kyu Seong | - |
dc.contributor.googleauthor | Jin Seok Jang | - |
dc.contributor.googleauthor | Jong-Jae Park | - |
dc.identifier.doi | 10.5009/gnl17416 | - |
dc.contributor.localId | A02812 | - |
dc.relation.journalcode | J00954 | - |
dc.identifier.eissn | 2005-1212 | - |
dc.identifier.pmid | 29938452 | - |
dc.subject.keyword | Compliance | - |
dc.subject.keyword | Efficacy | - |
dc.subject.keyword | Functional dyspepsia | - |
dc.subject.keyword | Mosapride | - |
dc.subject.keyword | Randomized clinical trial | - |
dc.contributor.alternativeName | Lee, Sang Kil | - |
dc.contributor.affiliatedAuthor | Lee, Sang Kil | - |
dc.citation.volume | 12 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 516 | - |
dc.citation.endPage | 522 | - |
dc.identifier.bibliographicCitation | GUT AND LIVER, Vol.12(5) : 516-522, 2018 | - |
dc.identifier.rimsid | 59041 | - |
dc.type.rims | ART | - |
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