Functional Dyspepsia
Conditions
Keywords
Functional Dyspepsia, FD, Prokinetics, Mosapride, DA-9701, Randomized, Double-blind, Multicenter
Brief summary
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.
Detailed description
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.
Interventions
DRUGMosapride citrate 5 mg + DA-9701 30 mg
Experimental: Mosapride citrate 5 mg + DA-9701 30 mg, Oral, 3 times/day, 30 min before meals for 4 weeks
DRUGMosapride citrate 5 mg + DA-9701 30 mg placebo
Placebo Comparator: Mosapride citrate 5 mg + DA-9701 placebo, Oral, 3 times/day, 30 min before meals for 4 weeks
Sponsors
Dong-A ST Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
Eunpyeong St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple: Participant, Care Provider, Investigator, Outcomes Assessor - Double-blind with placebo tablets matched to DA-9701
Intervention model description
Parallel Assignment - Two parallel arms comparing active prokinetic combination versus placebo comparator
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥19 years of age 2. Patients diagnosed with functional dyspepsia according to the Rome IV criteria, who can be classified as having postprandial distress syndrome * Rome IV criteria for functional dyspepsia: 1. One or more of the following symptoms: 1. Uncomfortable postprandial fullness 2. Early satiation 3. Epigastric pain 4. Epigastric burning 2. No evidence of structural disease that could explain the symptoms * Symptoms must have started at least 6 months before diagnosis and been present during the last 3 months 3. No history of gastrointestinal surgery 4. No organic lesions found on upper endoscopy within the past 3 months 5. Voluntarily signed informed consent to participate in this clinical trial
Exclusion criteria
1. Patients with confirmed structural diseases on upper gastrointestinal endoscopy, such as esophageal stricture, ulcer stricture, esophagogastric varices, Barrett's esophagus, active peptic ulcer, gastrointestinal bleeding, or eosinophilic esophagitis 2. Patients who have undergone surgery involving the esophagus, stomach, or duodenum 3. Patients with abnormal values in blood chemistry tests within the past month: * Total bilirubin, creatinine \> 1.5 times the upper limit of normal (ULN) * AST, ALT, alkaline phosphatase, BUN \> 2 times the ULN 4. Patients with diabetic gastroparesis 5. Patients with a history of drug or alcohol abuse within the past year 6. Pregnant or breastfeeding women -Patients currently taking medications that may affect the evaluation of the investigational drug's efficacy (e.g., acid-suppressing agents including PPIs, prokinetics, NSAIDs, anticholinergics, corticosteroids, antidepressants, erythromycin, mirtazapine, etc.) may only participate after a minimum 2-week wash-out period 7. Any other conditions that the investigator deems make the patient unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in overall dyspepsia symptoms at 4 weeks after drug administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in overall dyspepsia symptoms at 2 weeks after drug administration | 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. |
| Changes in dyspepsia symptom scores at 4 weeks after drug administration | 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. |
| Changes in sleep quality index scores at 4 weeks after drug administration | 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. |
Countries
South Korea
Outcome results
None listed