Status:
RECRUITING
DLBS2411 Treatment For Functional Dyspepsia
Lead Sponsor:
Dexa Medica Group
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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, f...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05248802
Start Date
December 9 2022
End Date
August 1 2025
Last Update
February 7 2025
Active Locations (8)
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1
Department of Internal Medicine, Dr. Kariadi General Hospital
Semarang, Central Java, Indonesia
2
Department of Internal Medicine, Universitas Sebelas Maret (UNS) Hospital
Sukoharjo, Central Java, Indonesia
3
Department of Internal Medicine, Dr. Moewardi Hospital
Surakarta, Central Java, Indonesia
4
Department of Internal Medicine, Budhi Asih Hospital
Jakarta, DKI Jakarta, Indonesia