J Neurogastroenterol Motil.  2024 Jan;30(1):106-115. 10.5056/jnm23147.

Clinical Trial: Efficacy of Mosapride Controlledrelease and Nortriptyline in Patients With Functional Dyspepsia: A Multicenter, Double-placebo, Double-blinded, Randomized Controlled, Parallel Clinical Study

• Tae CH
• Cha RR
• Oh JH
• Gweon TG
• Park JK
• Bang KB
• Song KH
• Huh CW
• Lee JY
• Shin CM
• Kim JW
• Youn YH
• Kwon JG
• Functional Dyspepsia Research Group under the Korean Society of Neurogastroenterology and Motility

• KMID: 2550587
• DOI: http://doi.org/10.5056/jnm23147

Abstract

Background/Aims
Prokinetic agents and neuromodulators are among the treatment options for functional dyspepsia (FD), but their comparative efficacy is unclear. We aimed to compare the efficacy of mosapride controlled-release (CR) and nortriptyline in patients with FD after 4 weeks of treatment.
Methods
Participants with FD were randomly assigned (1:1) to receive mosapride CR (mosapride CR 15 mg and nortriptyline placebo) or nortriptyline (mosapride CR placebo and nortriptyline 10 mg) in double-placebo, double-blinded, randomized controlled, parallel clinical study. The primary endpoint was defined as the proportion of patients with overall dyspepsia improvement after 4 weeks treatment. The secondary endpoints were changes in individual symptom scores, anxiety, depression, and quality of life.
Results
One hundred nine participants were recruited and assessed for eligibility, and 54 in the mosapride CR group and 50 in the nortriptyline group were included in the modified intention-to-treat protocol. The rate of overall dyspepsia improvement was similar between groups (53.7% vs 54.0%, P = 0.976). There was no difference in the efficacy of mosapride CR and nortriptyline in a subgroup analysis by FD subtype (59.3% vs 52.5% in postprandial distress syndrome, P = 0.615; 44.4% vs 40.0% in epigastric pain syndrome, P = > 0.999; 50.0% vs 59.1% in overlap, P = 0.565; respectively). Both treatments significantly improved anxiety, depression, and quality of life from baseline.
Conclusion
Mosapride CR and nortriptyline showed similar efficacy in patients with FD regardless of the subtype. Both treatments could be equally helpful for improving quality of life and psychological well-being while also relieving dyspepsia.

Keyword

Depression; Dyspepsia; Mosapride; Nortriptyline; Prokinetics