DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers (NCT02262169) | Clinical Trial Compass
TerminatedPhase 3
DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Stopped: This study was terminated due to internal technical issues at study site
Indonesia32 participantsStarted 2014-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.