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J Neurogastroenterol Motil. 2022;28(2):265-275.

A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of DA-9701 (Motilitone) in Patients With Constipation-type Irritable Bowel Syndrome and Functional Dyspepsia Overlap: A Pilot Study.

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제1저자 이주엽 · 교신저자 김나영

PMID 35232894 PMC8978125 DOI 10.5056/jnm20236 IF 3.7 소화기내과
소속 (3)
  1. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoungnam, Gyeonggi-do, Korea.
  2. Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
  3. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND/AIMS To assess the effects and safety of DA-9701 (Motilitone) in patients with constipation-type irritable bowel syndrome (IBS-C) which frequently accompany functional dyspepsia (FD).

METHODS FD and IBS-C were diagnosed based on the Rome III criteria. Randomized subjects were administered 30 mg of DA-9701 or placebo 3 times a day for 4 weeks. The study endpoints were evaluated the percentage of responders in the overall symptom evaluation of IBS-C and FD.

RESULTS Thirty IBS-C patients and 30 placebos were prospectively enrolled. The proportion of responders with improvement in overall symptoms of IBS-C was 53.33% in the DA-9701 group and 40.00% in the placebo group (P = 0.301). Compared to the placebo group, the decrease of abdominal pain score in the DA-9701 group was significantly higher at week 3 in the DA-9701 group (0.96 ± 0.77 vs 0.55 ± 0.79, P = 0.042) but no significance at week 4. There was no significant difference in total IBS quality of life score at week 4 between the 2 groups (P = 0.897). Among patients with IBS-C accompanied by FD, the proportion of responders in the DA- 9701 group was 50.00% (15/30), which was higher than 31.03% (9/29) of the placebo group (P = 0.138).

CONCLUSIONS DA-9701 showed trend of treatment efficacy in patients with IBS-C and FD overlap including overall improvement, and safety, compared to placebo but without significance probably due to small numbers. It is suggested the need for a large-scale clinical trial to confirm this preliminary effect of DA-9701.

Keywords

ConstipationDA-9701DyspepsiaIrritable bowel syndrome

Figures

Figure 1
Figure 1 Subject disposition and analysis population of the study. ITT, intention-to-treat; PP set, per protocol set.
Figure 2
Figure 2 Evaluation of constipation-type irritable bowel syndrome (IBS-C) symptoms. The proportion of responders with improvement in overall symptoms of IBS-C was 53.33% in the DA-9701 group and 40.00% in the placebo group (P = 0.301). Responder, the patients whose number of weeks in which symptoms were adequately improved in 75% of the total treatment period.
Figure 3
Figure 3 Changes in abdominal pain (A) and discomfort (B), stool consistency (C), and bowel movement (D) at weeks 1, 2, 3, and 4 compared to the baseline. Compared to the placebo group, the decrease abdominal pain score in the DA-9701 group tended to be higher, and the decrease at week 3 was significantly higher in the DA-9701 group (P = 0.042). Change 1 = 1 week – baseline; Change 2 = 2 weeks – baseline; Change 3 = 3 weeks – baseline; Change 4 = 4 weeks - baseline. *P < 0.05.
Figure 4
Figure 4 Changes in irritable bowel syndrome (IBS)–quality of life (QoL) at week 4 compared to the baseline. There was no significant difference in total IBS-QoL score at week 4 between the 2 groups (P = 0.897).
Figure 5
Figure 5 Subgroup analysis of functional dyspepsia. (A) The proportion of responders in the DA-9701 group was 50.00%, which was higher than 31.03% in the placebo group (P = 0.138). (B-D) Changes in the severity of symptoms including epigastric pain or soreness, early satiety, and postprandial fullness were not significantly different between the 2 groups. Change 1 = 1 week – baseline; Change 2 = 2 weeks – baseline; Change 3 = 3 weeks – baseline; Change 4 = 4 weeks – baseline.

그림 출처: PubMed Central 공개 논문 (PMC8978125)

Conflict of interest statement

Conflicts of interest: None.

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Journal Article
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Journal of neurogastroenterology and motility · ISSN 2093-0879
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