DLBS2411 Treatment For Functional Dyspepsia

NCT05248802 | Completed Phase 3

• 1 other identifier: DLBS2411-0419
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Functional Dyspepsia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Short-Form Nepean Dyspepsia Index (SF-NDI)

  Change of disease specific quality of life as measured by short-form NDI (SF-NDI) after 4 weeks of therapy (Week 4). The SF-NDI consists of 10 quality-of-life (QoL)-items, each of which is measured by 5-point Likert scales from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely). The lower score indicates an improved outcome.

  Week 4

Secondary Outcomes (4)

• Short-Form Nepean Dyspepsia Index (SF-NDI)

  Week 2 and 12

• Visual Analogue Scale (VAS)

  Week 2, 4, and 12

• The proportion of subjects reaching adequate / satisfactory relief from FD symptoms

  Week 2, 4, and 12

• Number of adverse event during the study

  Week 2, 4, and 12

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo DLBS2411 2 x 1 caplet daily, given everyday for 4 weeks of study period

Drug: Placebo caplet of DLBS2411

DLBS2411

EXPERIMENTAL

DLBS2411 caplet 2 x 250 mg daily, given everyday for 4 weeks of study period

Drug: DLBS2411

Interventions

Placebo caplet of DLBS2411 DRUG

1 caplet of placebo DLBS2411, twice daily

Also known as: Placebo caplet of Redacid

Control

DLBS2411 DRUG

1 caplet of DLBS2411 250 mg, twice daily

Also known as: Redacid

DLBS2411

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to participation in the study.
• Male or female subjects aged of 18 - 75 years old.
• Meet Rome IV criteria for FD, which includes:
• 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.
• 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.
• Subjects who tested negative for Helicobacter pylori by urea breath-test, histological or rapid test during the screening period.
• Able to take oral medication.

You may not qualify if:

• Pregnancy, breast-feeding females.
• Subjects suspected COVID-19 by clinical symptoms and rapid antigen test (reactive result) for SARS-COV-2.
• 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.
• History of or known or suspected Zollinger Ellison syndrome.
• History of or known gastrointestinal malignancy or ulcers associated to malignancy.
• Hepatic cirrhosis or abnormal liver laboratory findings (defined as \>3xULN of ALT or AST).
• Being under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR \<60 mL/min).
• 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%).
• 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.
• 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.
• Participation in any other clinical studies within 30 days prior to Screening.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (8)

Department of Internal Medicine, Dr. Kariadi General Hospital

Semarang, Central Java, Indonesia

Location

Department of Internal Medicine, Universitas Sebelas Maret (UNS) Hospital

Sukoharjo, Central Java, Indonesia

Location

Department of Internal Medicine, Dr. Moewardi Hospital

Surakarta, Central Java, Indonesia

Location

Department of Internal Medicine, Budhi Asih Hospital

Jakarta, DKI Jakarta, Indonesia

Location

Department of Internal Medicine, Fatmawati General Hospital

Jakarta, DKI Jakarta, Indonesia

Location

Department of Internal Medicine, Pasar Rebo Hospital

Jakarta, DKI Jakarta, Indonesia

Location

Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia

Surabaya, East Java, Indonesia

Location

Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Agasjtya W Wardhana, MD, Sp.PD-KGEH

  Department of Internal Medicine Budhi Asih Hospital, East Jakarta, Indonesia

  PRINCIPAL INVESTIGATOR

• Nugroho B Santoso, MD, Sp.PD

  Department of Internal Medicine Pasar Rebo Hospital, South Jakarta, Indonesia

  PRINCIPAL INVESTIGATOR

• Hery D Purnomo, Dr, MD, Sp.PD-KGEH

  Department of Internal Medicine Dr. Kariadi General Hospital, Semarang, Indonesia

  PRINCIPAL INVESTIGATOR

• Triyanta Y Pramana, Dr, MD, Sp.PD-KGEH

  Department of Internal Medicine Dr. Moewardi Hospital, Surakarta, Indonesia

  PRINCIPAL INVESTIGATOR

• Mulyana Edi, MD, Sp.PD-KGEH

  Department of Internal Medicine Fatmawati General Hospital, Jakarta,

  PRINCIPAL INVESTIGATOR

• Coana Sukmagautama, MD, Sp.PD, M.Kes.

  Department of Internal Medicine Universitas Sebelas Maret (UNS) Hospital, Sukoharjo, Indonesia

  PRINCIPAL INVESTIGATOR

• Ulfa Kholili, MD, Sp.PD-KGEH

  Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 21, 2022
• Study Start: December 9, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

ID (8)