Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study

Abstract

Background/Aims Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD. Methods In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed. Results The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD −10.04 ± 4.45 and −10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, −1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events. Conclusion In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.

Randomized Controlled Trial Comparing the Efficacy of Sustained-Release Formula of Mosapride-Plus-Esomeprazole Combination Therapy to Esomeprazole Monotherapy in Patients with Gastroesophageal Reflux Disease

“…Mosapride SR once a day has pharmacokinetic characteristics similar to those of conventional mosapride administered three times a day. In a previous study comparing the efficacy of mosapride SR and conventional mosapride in patients with functional dyspepsia, mosapride SR once daily was as effective as conventional mosapride three times daily, with a similar safety profile based on patient-reported symptom improvement and dyspepsia-specific QoL [ 19 ]. However, the effect of mosapride-SR addition to PPIs in patients with GERD has not been previously reported.…”

“…Recently, a sustained-release (SR) formula for mosapride, which is released at a constant rate over the whole day, has been developed to increase patient compliance with medication. Mosapride SR has been reported to be as effective as conventional mosapride release three times daily in patients with functional dyspepsia [ 19 ]. However, the benefits of the mosapride-SR addition to PPIs in patients with GERD have not been evaluated.…”

Efficacy and Safety of DWJ1252 Compared With Gasmotin Treatment: Once Met 3 Times Tablets

“…Small studies showed positive results but larger trials could not demonstrate significant efficacy. 3 In the Journal of Neurogastroenterology and Motility, a randomized clinical trial of 119 patients with FD (by Rome III criteria) conducted by Park et al 8 evaluated the efficacy and safety of once-a-day DWJ1252 (Gasmotin SR; Daewoong Pharm Co, LTD, Seoul, Korea), a sustained-release formulation of Gasmotin, compared with Gasmotin 3-times-a-day, in patients with FD. The primary endpoint was the change in gastrointestinal symptom (GIS) scores from baseline, assessed by GIS questionnaires on a 5-point Likert scale after 4 weeks of treatment.…”

“…A study by Park et al 8 regarding the efficacy of Gasmotin SR in FD lacked a placebo arm. In a randomized clinical trial of FD, the rate of response to the placebo was 30% to 60%.…”