This prospective, double-blinded, randomized, multicenter study will compare the efficacy and safety of two prokinetic regimens in patients with Rome IV-diagnosed functional dyspepsia. Ninety-two patients will be randomized (1:1) to receive either mosapride 5 mg + DA-9701 30 mg or mosapride 5 mg + matching placebo, three times daily before meals for 4 weeks. The primary endpoint is the proportion of overall responders ("much improved" or "very much improved" on a 7-point Likert scale) at Week 4. Secondary endpoints include overall response at Week 2, change in NDI-K symptom scores and PSQI-K sleep quality scores at Week 4, and safety assessments via laboratory tests and adverse-event monitoring.
A four-visit schedule: screening (Visit 1), randomization (Visit 2, same day), telephone follow-up at Week 2, and on-site assessment at Week 4. Screening includes informed consent, demographics, medical history, concomitant medications, labs, Rome IV questionnaire. Randomization uses opaque sealed envelopes generated by an independent statistician. Investigational products are dispensed in a double-dummy design to maintain blinding. Treatment compliance, vital signs, AEs collected at each contact. Efficacy via Likert scale, NDI-K, PSQI-K; safety via labs and AE reporting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Experimental: Mosapride citrate 5 mg + DA-9701 30 mg, Oral, 3 times/day, 30 min before meals for 4 weeks
Placebo Comparator: Mosapride citrate 5 mg + DA-9701 placebo, Oral, 3 times/day, 30 min before meals for 4 weeks
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea
Change in overall dyspepsia symptoms at 4 weeks after drug administration
At 4 weeks after drug administration, the 7-Likert scale(Overall Treatment Evaluation, OTE, 7-Likert scale) is used to assess change. Participants who report "very much improved" or "improved" are considered to show an overall response. The proportion of participants showing an overall response is compared across treatment groups based on the total number of subjects in each group. A responder is defined as a participant who is either symptom-free, reports being "very much improved," or "improved." A response is defined as a change of 50% or more in the total symptom score. The total score is calculated by either multiplying the severity of the four main symptoms or by multiplying both severity and frequency. The total score is defined as the average of the individual functional dyspepsia (FD) symptom scores.
Time frame: at 4 weeks after drug administration
Change in overall dyspepsia symptoms at 2 weeks after drug administration
The change in overall dyspeptic symptoms is measured using the 7-point Likert scale at 2 weeks after drug administration. Participants who report "very much improved" or "improved" are considered to show an overall response. The proportion of participants showing an overall response is compared across treatment groups based on the total number of subjects in each group. A responder is defined as a participant who is either symptom-free, reports being "very much improved," or "improved." A response is defined as a change of 50% or more in the total symptom score. The total score is calculated by either multiplying the severity of the four main symptoms or by multiplying both severity and frequency. The total score is defined as the average of the individual functional dyspepsia (FD) symptom scores.
Time frame: at 2 weeks after drug administration
Changes in dyspepsia symptom scores at 4 weeks after drug administration
Efficacy is assessed by comparing pre- and post-treatment scores over 4 weeks using the Korean version of the Nepean Dyspepsia Index(NDI-K). Specifically, the total score is calculated as the sum of frequency, intensity, and discomfort levels for 8 dyspeptic symptoms specific to functional dyspepsia among 15 symptoms: upper abdominal pain, upper abdominal discomfort, upper abdominal burning, early satiety, postprandial fullness, upper abdominal pressure, upper abdominal bloating, and nausea. Reductions in total score are categorized as follows: a reduction of 75% or more indicates a marked effect; 50-74%, a moderate effect; 25-49%, a mild effect; and less than 25%, no effect or worsening. This outcome measure is based on the NDI-K total score and uses scale points as the unit of measure.
Time frame: at 4 weeks after drug administration
Changes in sleep quality index scores at 4 weeks after drug administration
The Pittsburgh Sleep Quality Index-Korean version(PSQI-K) measures subjective sleep quality over the past month, consisting of 7 components across 19 items. Scores range from 0 (no sleep problems) to 21 (severe sleep disturbance), with a cutoff score of 5 distinguishing "good sleepers" (≤5) from "poor sleepers" (\>5). Changes in PSQI-K scores at 4 weeks after drug administration are assessed. This outcome measure uses the PSQI scoring scale as the unit of measure.
Time frame: at 4 weeks after drug administration
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