Clinical Trial: Efficacy of Mosapride Controlledrelease and Nortriptyline in Patients With Functional Dyspepsia: A Multicenter, Double-placebo, Double-blinded, Randomized Controlled, Parallel Clinical Study
- Author:
Chung Hyun TAE
1
;
Ra Ri CHA
;
Jung-Hwan OH
;
Tae-Guen GWEON
;
Jong Kyu PARK
;
Ki Bae BANG
;
Kyung Ho SONG
;
Cheal Wung HUH
;
Ju Yup LEE
;
Cheol Min SHIN
;
Jong Wook KIM
;
Young Hoon YOUN
;
Joong Goo KWON
;
Author Information
- Publication Type:Original Article
- From:Journal of Neurogastroenterology and Motility 2024;30(1):106-115
- CountryRepublic of Korea
- Language:English
-
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.
