J Neurogastroenterol Motil.  2022 Apr;28(2):265-275. 10.5056/jnm20236.

A Randomized, Double-blinded, Placebocontrolled 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

• Lee JY
• Kim N
• Yoon H
• Shin CM
• Park YS
• Lee DH

• KMID: 2528041
• DOI: http://doi.org/10.5056/jnm20236

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.

Keyword

DA-9701; Constipation; Dyspepsia; Irritable bowel syndrome