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DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

NCT02262169 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-07-09

No results posted yet for this study

Summary

This is a 2-arm, prospective, double-blind, double-dummy, randomized-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), or omeprazole at a dose of 40 mg once daily (before morning meal), for an 8-week course of therapy, for the treatment of patients with any non-bleeding peptic ulcers.

DLBS2411 is a bioactive fraction of an Indonesian native herbal, Cinnamomum burmanii, locally known as kayu manis have been proven 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 gastro-protective defense mechanism works through the promotion of COX-2 derived prostaglandin (PgE2) synthesis, stimulating gastric-epithelial mucous and bicarbonate secretion; anti-oxidative activity; and endothelial-nitric oxide (NO) formation.

Recent study of DLBS2411 in healthy volunteers demonstrated the effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is hypothesized to benefit in peptic ulcers.

Conditions

  • Non-Bleeding Peptic Ulcers

Interventions

DRUG

Omeprazole

2 Omeprazole capsules 20 mg, once daily

DRUG

Placebo caplet of DLBS2411

1 placebo caplet of DLBS2411, twice daily

DRUG

DLBS2411

1 DLBS2411 caplet 250 mg, twice daily

DRUG

Placebo capsule of Omeprazole

2 placebo capsules of Omeprazole, once daily

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • IDN Wibawa Prof. DR. Dr., SpPD-KGEH · Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-02-28
Completion
2019-03-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02262169 on ClinicalTrials.gov