Korean J Gastroenterol.  2021 Apr;77(4):171-178. 10.4166/kjg.2020.171.

Multicenter, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of a Controlled-release, Once-daily UIC201609/UIC201610 Combination Therapy for Functional Dyspepsia: Preliminary Study

Affiliations
  • 1Department of Internal medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
  • 2Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
  • 3Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 4Department of Internal Medicine, Digestive Disease Research Institute, Wonkwang University College of Medicine, Iksan, Korea
  • 5Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
  • 6Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea

Abstract

Background/Aims
Functional dyspepsia is a disease involving a range of upper gastrointestinal symptoms derived from various pathophysiologies. Tablets containing a combination of rabeprazole and controlled-release (CR) mosapride were recently developed. To investigate a more effective treatment, this trial evaluated the efficacy and safety of UIC201609/UIC201610 as a preliminary study.
Methods
A multicenter, double-blind, randomized study was performed on 30 subjects. UIC201609/UIC201610 (combination of rabeprazole and CR mosapride) was the case group, and the two control groups were rabeprazole 10 mg once a day and mosapride 15 mg CR tablet once a day. As a primary efficacy endpoint of the study, the changes in the total score of eight items of the Nepean Dyspepsia Index-Korean version were analyzed at 2 weeks and 4 weeks. The outcomes regarding safety were collected.
Results
The total symptom score of Nepean Dyspepsia Index-Korean decreased in the rabeprazole single group (29.4±17.1), mosapride CR single group (33.4±15.6), and UIC201609/UIC201610 group (33.4±11.8) at 4 weeks without significant differences. On the other hand, the UIC201609/UIC201610 combination group showed more score reduction of pain in the upper abdomen, burning in the upper abdomen compared to each control group, but it did not reach statistical significance. No difference was found in safety analysis.
Conclusions
UIC201609/UIC201610 once daily showed some improvement in epigastric pain and dyspepsia in patients with functional dyspepsia, but there was no significance. Further study based on the advanced clinical trial design will be needed to confirm the efficacy of UIC201609/UIC201610 combination therapy in the future.

Keyword

Stomach; Functional dyspepsia; Treatment outcome; Patient safety; Mosapride
Full Text Links
  • KJG
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
    DB Error: unknown error