The Effect of Two Prokinetics in Patients With Functional Dyspepsia

NCT07096921 | Active Not Recruiting

• 1 other identifier: PC25MIDI0023
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia; FD; Prokinetics; Mosapride; DA-9701; Randomized; Double-blind; Multicenter

Outcome Measures

Primary Outcomes (1)

• 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.

  at 4 weeks after drug administration

Secondary Outcomes (3)

• Change in overall dyspepsia symptoms at 2 weeks after drug administration

  at 2 weeks after drug administration

• Changes in dyspepsia symptom scores at 4 weeks after drug administration

  at 4 weeks after drug administration

• Changes in sleep quality index scores at 4 weeks after drug administration

  at 4 weeks after drug administration

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental: Mosapride citrate 5 mg + DA-9701 30 mg, Oral, 3 times/day, 30 min before meals for 4 weeks

Drug: Mosapride citrate 5 mg + DA-9701 30 mg

Placebo

PLACEBO COMPARATOR

Placebo Comparator: Mosapride citrate 5 mg + DA-9701 placebo, Oral, 3 times/day, 30 min before meals for 4 weeks

Drug: Mosapride citrate 5 mg + DA-9701 30 mg placebo

Interventions

Mosapride citrate 5 mg + DA-9701 30 mg DRUG

Experimental: Mosapride citrate 5 mg + DA-9701 30 mg, Oral, 3 times/day, 30 min before meals for 4 weeks

Also known as: Gasmotin Tab. 5mg + Motilitone Tab.

Experimental

Mosapride citrate 5 mg + DA-9701 30 mg placebo DRUG

Placebo Comparator: Mosapride citrate 5 mg + DA-9701 placebo, Oral, 3 times/day, 30 min before meals for 4 weeks

Also known as: Gasmotin Tab. 5mg + Motilitone Tab. placebo

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥19 years of age
• 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:
• One or more of the following symptoms:
• Uncomfortable postprandial fullness
• Early satiation
• Epigastric pain
• Epigastric burning
• 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
• No history of gastrointestinal surgery
• No organic lesions found on upper endoscopy within the past 3 months
• Voluntarily signed informed consent to participate in this clinical trial

You may not qualify if:

• 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
• Patients who have undergone surgery involving the esophagus, stomach, or duodenum
• 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
• Patients with diabetic gastroparesis
• Patients with a history of drug or alcohol abuse within the past year
• 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
• Any other conditions that the investigator deems make the patient unsuitable for participation in the study

Sponsors & Collaborators

• Eunpyeong St. Mary's Hospital: lead
• Dong-A ST Co., Ltd.: collaborator
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, 03312, South Korea

Location

MeSH Terms

Interventions

mosapride; DA-9701

Study Officials

• JUNG HWAN OH

  The Catholic University of Korea Eunpyeong St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple: Participant, Care Provider, Investigator, Outcomes Assessor - Double-blind with placebo tablets matched to DA-9701
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Model Details: Parallel Assignment - Two parallel arms comparing active prokinetic combination versus placebo comparator

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 31, 2025
• Study Start: July 8, 2025
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)