Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial
- 주제(키워드) Mosapride , Functional dyspepsia , Compliance , Efficacy , Randomized clinical trial
- 주제(기타) Gastroenterology & Hepatology
- 설명문(일반) [Yoon, Hyuk; Lee, Dong Ho] Seoul Natl Univ, Dept Internal Med, Bundang Hosp, 82 Gumi Ro 173beou Gil, Seongnam 13620, South Korea; [Lee, Yong-Hyun; Jeong, Ju-Cheol] Korea United Pharm Inc, Dept Clin Res, Seoul, South Korea; [Lee, Soo Teik] Chonbuk Natl Univ Hosp, Dept Internal Med, Jeonju, South Korea; [Choi, Myung-Gyu] Catholic Univ Korea, Seoul St Marys Hosp, Dept Internal Med, Seoul, South Korea; [Jeon, Seong Woo] Kyungpook Natl Univ, Dept Internal Med, Med Ctr, Daegu, South Korea; [Shim, Ki-Nam] Ewha Womans Univ, Dept Internal Med, Sch Med, Med Res Inst, Seoul, South Korea; [Baik, Gwang Ho] Hallym Univ, Coll Med, Chuncheon Sacred Heart Hosp, Dept Internal Med, Chunchon, South Korea; [Kim, Jae Gyu] Chung Ang Univ, Dept Internal Med, Coll Med, Seoul, South Korea; [Moon, Jeong Seop] Inje Univ, Dept Internal Med, Seoul Palk Hosp, Coll Med, Seoul, South Korea; [Sung, In-Kyung] Konkuk Univ, Dept Internal Med, Coll Med, Seoul, South Korea; [Lee, Sang Kil] Yonsei Univ, Severance Hosp, Dept Internal Med, Coll Med, Seoul, South Korea; [Rhee, Poong-Lyul] Sungkyunkwan Univ, Samsung Med Ctr, Dept Med, Sch Med, Seoul, South Korea; [Jung, Hwoon-Yong] Ulsan Univ, Coll Med, Asan Med Ctr, Dept Internal Med, Seoul, South Korea; [Lee, Bong Eun] Pusan Natl Univ Hosp, Dept Gastroenterol, Busan, South Korea; [Kim, Hyun Soo] Chonnam Natl Univ Hosp, Dept Internal Med, Gwangju, South Korea; [Kim, Sang Gyun] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea; [Lee, Kee Myung] Ajou Univ, Dept Gastroenterol, Sch Med, Suwon, South Korea; [Seong, Jae Kyu] Chungnam Natl Univ Hosp, Dept Internal Med, Daejeon, South Korea; [Jang, Jin Seok] Dong A Univ Hosp, Dept Gastroenterol, Busan, South Korea; [Park, Jong-Jae] Korea Univ, Dept Internal Med, Guro Hosp, Seoul, South Korea
- 등재 SCIE, SCOPUS, KCI등재
- 발행기관 EDITORIAL OFFICE GUT & LIVER
- 발행년도 2018
- URI http://www.dcollection.net/handler/ewha/000000156012
- 본문언어 영어
- Published As http://dx.doi.org/10.5009/gnl17416
초록/요약
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.
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