DLBS2411 Treatment For Functional Dyspepsia

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 2-arm, prospective, double-blind, randomized and placebo-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), for a 4-week course of therapy, for the treatment of patients with functional dyspepsia (FD), and an additional 8 weeks after end of therapy (Week 12) for follow-up visit.

The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation. The mechanism altogether demonstrated DLBS2411's protective capacity to the gastric and colon mucosa by promoting mucous synthesis and stimulating mucosal blood flow.

Having such mechanisms of action, DLBS2411 is hypothesized to benefit subjects with gastric acid disorders such as in functional dyspepsia, gastro-intestinal reflux disease (GERD), peptic-ulcer, and irritable bowel syndrome (IBS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

Criteria

Key Inclusion Criteria:

1. Signed informed consent prior to participation in the study.

2. Male or female subjects aged of 18 - 75 years old.

3. Meet Rome IV criteria for FD, which includes:

1. One or more of the following symptoms:

• bothersome postprandial fullness

• early satiation, that prevents finishing a regular meal, at least several times per week.

• epigastric pain, epigastric burning. The symptoms are persistently present (i.e. occurring at least one day per month (for male) or 2-3 days per month (for female) for at least the past 3 months with symptom onset at least 6 months prior to study Screening.

2. Having no evidence of structural or organic gastrointestinal (GI) disease that is likely to explain the symptoms, as verified by a normal esophagogastroduodenoscopy (EGD) performed within the past 3 years.

4. Subjects who tested negative for Helicobacter pylori by urea breath-test, or histological test during the screening period or the previous 12 months.

5. Able to take oral medication.

Key Exclusion Criteria:

1. Pregnancy, breast-feeding females.

2. Subjects suspected COVID-19 by clinical symptoms and rapid antigen test (reactive result) for SARS-COV-2.

3. GERD as confirmed by any documented history of endoscopic esophagitis, or clinical symptoms such as predominant heartburn or acid regurgitation, >2x/week in the prior year.

4. History of or known or suspected Zollinger Ellison syndrome.

5. History of or known gastrointestinal malignancy or ulcers associated to malignancy.

6. Hepatic cirrhosis or abnormal liver laboratory findings (defined as >3xULN of ALT or AST).

7. Being under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR <60 mL/min).

8. History of or known congestive heart failure NYHA class III and IV, or any other uncontrolled chronic diseases, such as: uncontrolled hypertension (systolic/diastolic blood pressure ≥160/100 mmHg); uncontrolled diabetes (HbA1c >8%).

9. Currently known being afflicted by serious infection(s), or any known severe illness(es) which are judged by the Investigator could interfere with subjects' safety and/or study evaluation.

10. Taking medication affecting the gastrointestinal system within 2 weeks prior to Screening, such as: prokinetics, acid release inhibitors (histamine-2-receptor [H2]- antagonists, proton pump inhibitors [PPI], or potassium-competitive acid blockers), gastric mucosa protectors (sucralfate, rebamipide), and any gastric-relevant herbal medicines.

11. Participation in any other clinical studies within 30 days prior to Screening.