Treatment for Functional Dyspepsia with DLBS2411

Randomized Controlled Trial of DLBS2411 Treatment For Functional Dyspepsia

This study is testing a new treatment called DLBS2411 to see if it can help people with functional dyspepsia feel better by reducing symptoms like stomach pain and fullness after eating.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Dexa Medica Group (Industry-sponsored)
• Locations: 8 sites (Semarang, Central Java and 7 other locations)
• Trial ID: NCT05248802 on ClinicalTrials.gov

What this trial studies

This clinical trial is a double-blind, randomized, placebo-controlled study evaluating the efficacy of DLBS2411 in treating functional dyspepsia. Participants will receive either DLBS2411 or a placebo for four weeks, followed by an eight-week follow-up period. The study aims to assess the drug's ability to alleviate symptoms such as postprandial fullness and epigastric pain. The trial will involve 100 subjects, with regular clinic visits for monitoring and evaluation of safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who meet the Rome IV criteria for functional dyspepsia and have no evidence of structural gastrointestinal disease.

Not a fit: Patients with structural gastrointestinal diseases or those who test positive for Helicobacter pylori may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from functional dyspepsia.

How similar studies have performed: Other studies have shown promise in treating functional dyspepsia with similar approaches, but the specific use of DLBS2411 is novel.

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.

Where this trial is running

Semarang, Central Java and 7 other locations

• Department of Internal Medicine, Dr. Kariadi General Hospital — Semarang, Central Java, Indonesia (Recruiting)
• Department of Internal Medicine, Universitas Sebelas Maret (UNS) Hospital — Sukoharjo, Central Java, Indonesia (Recruiting)
• Department of Internal Medicine, Dr. Moewardi Hospital — Surakarta, Central Java, Indonesia (Recruiting)
• Department of Internal Medicine, Budhi Asih Hospital — Jakarta, DKI Jakarta, Indonesia (Suspended)
• Department of Internal Medicine, Fatmawati General Hospital — Jakarta, DKI Jakarta, Indonesia (Recruiting)
• Department of Internal Medicine, Pasar Rebo Hospital — Jakarta, DKI Jakarta, Indonesia (Recruiting)
• Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia — Surabaya, Jawa Timur, Indonesia (Not_yet_recruiting)
• Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital — Jakarta, Indonesia (Recruiting)

Study contacts

• Principal investigator: Ari F Syam, Prof, MD, Sp.PD-KGEH — Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta Indonesia
• Study coordinator: Ari F Syam, Prof, MD, Sp.PD-KGEH

Conditions Functional Dyspepsia; DLBS2411; Epigastric Pain Syndrome; Postprandial Distress Syndrome