Gut Liver.  2018 Sep;12(5):516-522. 10.5009/gnl17416.

Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial

Affiliations
  • 1Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. dhljohn@yahoo.co.kr
  • 2Department of Clinical Research, Korea United Pharm. Inc., Seoul, Korea.
  • 3Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea.
  • 4Department of Internal Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea.
  • 5Department of Internal Medicine, Kyungpook National University Medical Center, Daegu, Korea.
  • 6Department of Internal Medicine, Medical Research Institute, Ewha Womans University School of Medicine, Seoul, Korea.
  • 7Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.
  • 8Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
  • 9Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.
  • 10Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.
  • 11Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 12Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 13Department of Internal Medicine, Asan Medical Center, Ulsan University College of Medicine, Seoul, Korea.
  • 14Department of Gastroenterology, Pusan National University Hospital, Busan, Korea.
  • 15Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
  • 16Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
  • 17Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.
  • 18Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.
  • 19Department of Gastroenterology, Dong-A University Hospital, Busan, Korea.
  • 20Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.

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.

Keyword

Mosapride; Functional dyspepsia; Compliance; Efficacy; Randomized clinical trial

MeSH Terms

Compliance
Dyspepsia*
Humans
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