DLBS2411 Treatment for Functional Dyspepsia

Launched by DEXA MEDICA GROUP · Feb 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DLBS2411 for people with functional dyspepsia (FD), a condition that causes uncomfortable symptoms like bloating, early fullness when eating, and pain in the upper stomach. The trial is looking for participants aged 18 to 75 who have been experiencing these symptoms regularly and have no other underlying gastrointestinal diseases. Participants will take DLBS2411 twice a day for four weeks, and then there will be follow-up visits to see how they are doing over the next eight weeks.

To be eligible, you need to have signed consent to join the study and have specific symptoms that fit the study's guidelines. Importantly, you should not have any serious gastrointestinal issues or be pregnant. During the study, you will receive either the treatment or a placebo (a pill with no active ingredients) without knowing which one you’re taking, to ensure a fair test of the treatment’s effectiveness. This trial aims to find out if DLBS2411 can help improve symptoms for people suffering from FD, potentially offering a new option for treatment.

Gender

ALL

Eligibility 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, histological or rapid test during the screening period.
• • 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 c ≥7%).
• • 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.