DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

• Status: Terminated
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Male or female subjects aged 18-75 years old.

• Diagnosed as non-bleeding peptic ulcers who do not require endoscopic therapy, as confirmed by :

• The presence of endoscopically confirmed gastric or duodenal ulcer(s) at size(s) of at least 3 mm or larger.

• Subjects with low-risk of recurrent bleeding, defined as both:

• Complete Rockall score of ≤ 7.

• Endoscopic stigmata (lesion) of grade II-C or III based on Forrest classification.

• Able to take oral medication.

Exclusion Criteria:

• For females of childbearing potential: pregnancy, breast-feeding, the intention of becoming pregnant during the study participation.

• Patients must accept pregnancy tests during the trial if menstrual cycle is missed

• Fertile patients must use a reliable and effective contraceptive

• History of or known or suspected Zollinger Ellison syndrome.

• History of endoscopic therapy for bleeding ulcer within the past 4 weeks.

• Indication for endoscopic hemostasis therapy.

• Presence of Helicobacter pylori infection

• History of or known coronary artery disease (CAD), congestive heart failure, pulmonary disease, and any other uncontrolled chronic diseases.

• History of or known gastrointestinal malignancy or ulcers associated to malignancy.

• Currently known being afflicted by serious infection(s).

• Inadequate liver function

• Inadequate renal function

• Subjects being under therapy with any herbal medicines.

• Known hypersensitivity or idiosyncratic reaction or adverse drug reactions to proton pump inhibitors (PPIs).

• Participation in any other clinical studies within 30 days prior to screening.