- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05248802
DLBS2411 Treatment For Functional Dyspepsia
Randomized Controlled Trial of DLBS2411 Treatment For Functional Dyspepsia
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study population will be patients with functional dyspepsia (FD) who come to the study site. There will be 100 subjects (50 subjects in each group) planned to be enrolled in the study.
There will be 2 groups of treatment; Treatment 1: placebo DLBS2411 caplet Treatment 2: DLBS2411 250 mg caplet Each study medication will be administered 1 caplet twice daily, 30 minutes before meal, in the morning and evening.
Eligible subjects will be randomly allocated to receive either Treatment 1 or Treatment 2 for 4 weeks, in a double blind fashion. Subjects will be instructed to come to the clinic every 2-week interval throughout the 4-week study period (at Week 2, and 4, respectively) and 8 weeks after the end of therapy (Week 12), for efficacy evaluation. The safety evaluation will be performed at Baseline and End of therapy (Week 4). Adverse events will be monitored at baseline and every follow-up visit including End of study (Week 12).
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Ari F Syam, Prof, MD, Sp.PD-KGEH
- Phone Number: +62818706199
- Email: ari_syam@hotmail.com
Study Contact Backup
- Name: Liana W Susanto, MBiomed
- Phone Number: +628129507176
- Email: liana.wijaya@dexa-medica.com
Study Locations
-
-
-
Jakarta, Indonesia, 10430
- Recruiting
- Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital
-
Contact:
- Ari F Syam, Prof, MD, Sp.PD-KGEH
- Phone Number: +6221 3153957
- Email: ari_syam@hotmail.com
-
Principal Investigator:
- Ari F Syam, Prof, MD, Sp.PD-KGEH
-
Sub-Investigator:
- Hasan Maulahela, MD, Sp.PD-KGEH
-
Sub-Investigator:
- Rabbinu R Pribadi, MD, Sp.PD
-
-
Central Java
-
Semarang, Central Java, Indonesia
- Recruiting
- Department of Internal Medicine, Dr. Kariadi General Hospital
-
Principal Investigator:
- Hery D Purnomo, MD, Sp.PD-KGEH
-
Sub-Investigator:
- Hesti T Hutami, MD, Sp.PD
-
Sub-Investigator:
- Cecilia O Permatadewi, MD, Sp.PD
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Contact:
- Hery D Purnomo, Dr, MD, Sp.PD-KGEH
- Phone Number: +6224 841 3993
- Email: herydjagat@yahoo.co.id
-
Sukoharjo, Central Java, Indonesia
- Recruiting
- Department of Internal Medicine, Universitas Sebelas Maret (UNS) Hospital
-
Contact:
- Coana Sukmagautama, MD, Sp.PD, M.Kes
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Principal Investigator:
- Coana Sukmagautama, MD, Sp.PD, M.Kes
-
Sub-Investigator:
- Desy Puspa Putri, Sp.PD
-
Surakarta, Central Java, Indonesia
- Recruiting
- Department of Internal Medicine, Dr. Moewardi Hospital
-
Principal Investigator:
- Triyanta Y Pramana, MD, Sp.PD-KGEH
-
Sub-Investigator:
- Aritantri Darmayani, MD, Sp.PD-KGEH
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Sub-Investigator:
- Didik Prasetyo, MD, Sp.PD
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Contact:
- Triyanta Y Pramana, Dr, MD, Sp.PD-KGEH
- Phone Number: +62271 634 634
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-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia
- Recruiting
- Department of Internal Medicine, Pasar Rebo Hospital
-
Contact:
- Nugroho B Santoso, MD, Sp.PD
- Phone Number: +6221 8400 109
-
Principal Investigator:
- Nugroho B Santoso, MD, Sp.PD
-
Sub-Investigator:
- Ariadi Humardhani, MD, Sp.PD
-
Jakarta, DKI Jakarta, Indonesia
- Recruiting
- Department of Internal Medicine, Budhi Asih Hospital
-
Contact:
- Agasjtya W Wardhana, MD, Sp.PD-KGEH
- Phone Number: +6221 809 0282
-
Principal Investigator:
- Agasjtya W Wardhana, MD, Sp.PD-KGEH
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Sub-Investigator:
- Lela D Sary, MD, Sp.FK
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Jakarta, DKI Jakarta, Indonesia
- Recruiting
- Department of Internal Medicine, Fatmawati General Hospital
-
Contact:
- Edi Mulyana, MD, Sp.PD-KGEH
-
Principal Investigator:
- Edi Mulyana, MD, Sp.PD-KGEH
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Sub-Investigator:
- Nikko Darnindro, MD, Sp.PD
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Sub-Investigator:
- Annela Manurung, MD, Sp.PD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Placebo DLBS2411 2 x 1 caplet daily, given everyday for 4 weeks of study period
|
1 caplet of placebo DLBS2411, twice daily
Other Names:
|
Experimental: DLBS2411
DLBS2411 caplet 2 x 250 mg daily, given everyday for 4 weeks of study period
|
1 caplet of DLBS2411 250 mg, twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-Form Nepean Dyspepsia Index (SF-NDI)
Time Frame: Week 4
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-Form Nepean Dyspepsia Index (SF-NDI)
Time Frame: Week 2 and 12
|
Change of disease specific quality of life as measured by short-form NDI (SF-NDI) after 2 weeks of therapy (Week 2) and additional 8 weeks after end of therapy (Week 12). 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 2 and 12
|
Visual Analogue Scale (VAS)
Time Frame: Week 2, 4, and 12
|
Change of the individual symptom intensity as indicated by Visual Analogue Scale (VAS) reduction after 2 and 4 weeks of therapy and 8 weeks after the end of therapy (Week 2, 4 and 12, respectively). The VAS of pain intensity is rated from 0 to 100 on a 100-mm line, with the end points indicating: no pain (0) and the worst pain it could possible be (100). |
Week 2, 4, and 12
|
The proportion of subjects reaching adequate / satisfactory relief from FD symptoms
Time Frame: Week 2, 4, and 12
|
The proportion of subjects reaching adequate / satisfactory relief from FD symptoms based on subjects" subjective evaluation on overall symptom relief at Week 2, Week 4 and additional 8 weeks after end of therapy (Week 12)
|
Week 2, 4, and 12
|
Number of adverse event during the study
Time Frame: Week 2, 4, and 12
|
Number of adverse event during the study will be observed throughout the study conduct
|
Week 2, 4, and 12
|
Collaborators and Investigators
Sponsor
Investigators
- 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
- 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: 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: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLBS2411-0419
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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