Status:
TERMINATED
DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Lead Sponsor:
Dexa Medica Group
Conditions:
Non-Bleeding Peptic Ulcers
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 m...
Detailed Description
A total of 140 subjects will be allocated into 2 groups of treatment; each group will consist of 70 subjects with the treatment regimens: Treatment I : 2 capsules of Omeprazole 20 mg, once daily and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02262169
Start Date
October 1 2014
End Date
March 1 2019
Last Update
July 9 2019
Active Locations (1)
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1
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
Denpasar, Bali, Indonesia, 80114