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DLBS2411 Treatment For Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status

Recruiting

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Placebo caplet of DLBS2411

DLBS2411

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, DLBS2411, Epigastric Pain Syndrome, Postprandial Distress Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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.
Subjects who tested negative for Helicobacter pylori by urea breath-test, or histological test during the screening period or the previous 12 months.
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 >8%).
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.

Sites / Locations

Department of Internal Medicine, Dr. Kariadi General HospitalRecruiting
Department of Internal Medicine, Universitas Sebelas Maret (UNS) HospitalRecruiting
Department of Internal Medicine, Dr. Moewardi HospitalRecruiting
Department of Internal Medicine, Budhi Asih HospitalRecruiting
Department of Internal Medicine, Fatmawati General HospitalRecruiting
Department of Internal Medicine, Pasar Rebo HospitalRecruiting
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

DLBS2411

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Short-Form Nepean Dyspepsia Index (SF-NDI)

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.

Visual Analogue Scale (VAS)

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).

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

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)

Number of adverse event during the study

Number of adverse event during the study will be observed throughout the study conduct

Full Information

NCT ID

NCT05248802

First Posted

January 26, 2022

Last Updated

September 6, 2023

Sponsor

Dexa Medica Group

1. Study Identification

Unique Protocol Identification Number

NCT05248802

Brief Title

DLBS2411 Treatment For Functional Dyspepsia

Official Title

Randomized Controlled Trial of DLBS2411 Treatment For Functional Dyspepsia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2022 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dexa Medica Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Dyspepsia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

DLBS2411

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo caplet of DLBS2411

Other Intervention Name(s)

Placebo caplet of Redacid

Intervention Description

1 caplet of placebo DLBS2411, twice daily

Intervention Type

Drug

Intervention Name(s)

DLBS2411

Other Intervention Name(s)

Redacid

Intervention Description

1 caplet of DLBS2411 250 mg, twice daily

Primary Outcome Measure Information:

Title

Short-Form Nepean Dyspepsia Index (SF-NDI)

Description

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

Short-Form Nepean Dyspepsia Index (SF-NDI)

Description

Time Frame

Week 2 and 12

Title

Visual Analogue Scale (VAS)

Description

Time Frame

Week 2, 4, and 12

Title

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

Description

Time Frame

Week 2, 4, and 12

Title

Number of adverse event during the study

Description

Number of adverse event during the study will be observed throughout the study conduct

Time Frame

Week 2, 4, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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, or histological test during the screening period or the previous 12 months. 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 >8%). 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ari F Syam, Prof, MD, Sp.PD-KGEH

Phone

+62818706199

ari_syam@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Liana W Susanto, MBiomed

Phone

+628129507176

liana.wijaya@dexa-medica.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ari F Syam, Prof, MD, Sp.PD-KGEH

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Agasjtya W Wardhana, MD, Sp.PD-KGEH

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nugroho B Santoso, MD, Sp.PD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hery D Purnomo, MD, Sp.PD-KGEH

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Triyanta Y Pramana, MD, Sp.PD-KGEH

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mulyana Edi, MD, Sp.PD-KGEH

Organizational Affiliation

Department of Internal Medicine Fatmawati General Hospital, Jakarta,

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Internal Medicine, Dr. Kariadi General Hospital

City

Semarang

State/Province

Central Java

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hery D Purnomo, MD, Sp.PD-KGEH

Phone

+6224 841 3993

herydjagat@yahoo.co.id

First Name & Middle Initial & Last Name & Degree

Hery D Purnomo, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Hesti T Hutami, MD, Sp.PD

First Name & Middle Initial & Last Name & Degree

Cecilia O Permatadewi, MD, Sp.PD

Facility Name

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

City

Sukoharjo

State/Province

Central Java

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

First Name & Middle Initial & Last Name & Degree

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

First Name & Middle Initial & Last Name & Degree

Desy Puspa Putri, Sp.PD

Facility Name

Department of Internal Medicine, Dr. Moewardi Hospital

City

Surakarta

State/Province

Central Java

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Triyanta Y Pramana, MD, Sp.PD-KGEH

Phone

+62271 634 634

First Name & Middle Initial & Last Name & Degree

Triyanta Y Pramana, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Aritantri Darmayani, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Didik Prasetyo, MD, Sp.PD

Facility Name

Department of Internal Medicine, Budhi Asih Hospital

City

Jakarta

State/Province

DKI Jakarta

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agasjtya W Wardhana, MD, Sp.PD-KGEH

Phone

+6221 809 0282

First Name & Middle Initial & Last Name & Degree

Agasjtya W Wardhana, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Lela D Sary, MD, Sp.FK

Facility Name

Department of Internal Medicine, Fatmawati General Hospital

City

Jakarta

State/Province

DKI Jakarta

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edi Mulyana, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Edi Mulyana, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Nikko Darnindro, MD, Sp.PD

Facility Name

Department of Internal Medicine, Pasar Rebo Hospital

City

Jakarta

State/Province

DKI Jakarta

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nugroho B Santoso, MD, Sp.PD

Phone

+6221 8400 109

First Name & Middle Initial & Last Name & Degree

Nugroho B Santoso, MD, Sp.PD

First Name & Middle Initial & Last Name & Degree

Ariadi Humardhani, MD, Sp.PD

Facility Name

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

City

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ari F Syam, Prof, MD, Sp.PD-KGEH

Phone

+6221 3153957

ari_syam@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ari F Syam, Prof, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Hasan Maulahela, MD, Sp.PD-KGEH

First Name & Middle Initial & Last Name & Degree

Rabbinu R Pribadi, MD, Sp.PD

12. IPD Sharing Statement

Learn more about this trial

DLBS2411 Treatment For Functional Dyspepsia

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