Back to resultsDLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Primary Purpose
Non-Bleeding Peptic Ulcers
Status
Terminated
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Omeprazole
Placebo caplet of DLBS2411
DLBS2411
Placebo capsule of Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Non-Bleeding Peptic Ulcers focused on measuring Non-Bleeding Peptic Ulcers, DLBS2411, Ulcer Healing
Eligibility 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.
Sites / Locations
- Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment I
Treatment II
Arm Description
2 Omeprazole capsules 20 mg once daily and 1 placebo caplet of DLBS2411, twice daily
1 DLBS2411 caplet 250 mg twice daily and 2 placebo capsules of Omeprazole once daily
Outcomes
Primary Outcome Measures
Endoscopic ulcer healing rate
Endoscopic ulcer healing rate after 8 weeks of treatment. Ulcer healing rate is defined as the proportion of subjects with complete ulcer-healing (referring to S1 or S2 Scarring stage according to Sakita-Fukutomi classification) as confirmed by endoscopic finding.
Secondary Outcome Measures
The improvement rate of each of gastric symptoms
The improvement rate of each of gastric symptoms at each of the follow-up visits (after 4 and 8 weeks of treatment):
abdominal or epigastric pain (middle or upper stomach)
nausea or vomiting,
bloating
The quality of ulcer healing
The quality of ulcer healing as measured by the levels of gastric mucosal bFGF (basic fibroblast growth factor) and COX-2 (cyclo-oxygenase), at baseline and Week 8 of treatment.
Mucosal thickness
Gastric mucosal thickness will be measured quantitatively as the expression of MUC5AC by immunohistochemistry (IHC) method, at baseline and Week 8 of treatment.
Patients' global evaluation for their symptoms
Patients' global evaluation for their symptoms categorized as: no improvement or slightly improved or moderately improved or markedly improved, at Week 4 and 8 (end of study).
Liver function
Liver function (serum ALT (alanine-aminotransferase), serum AST (aspartate-aminotransferase), alkaline phosphatase, total bilirubin) at baseline and at the end of study
Renal function
Renal function (serum creatinine and BUN (blood urea nitrogen) level) at baseline and at the end of study
Adverse events
Adverse event, will be observed throughout the study conduct
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02262169
Brief Title
DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Official Title
DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to internal technical issues at study site
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 1 placebo caplet of DLBS2411, twice daily Treatment II : 1 caplet of DLBS2411 250 mg, twice daily and 2 placebo capsules of omeprazole, once daily
DLBS2411 will be administered twice daily at least 30 minutes before morning and evening meals, while omeprazole, once daily before morning meals, for 8 weeks of study period.
The eligible subjects will receive either study medication (Treatment 1 or Treatment 2), for 8 weeks of treatment; and will be instructed to come to the clinic every 4-week interval throughout the study period.
Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over the 8-week course of therapy.
The safety profile of study medication other than vital signs and adverse event will be measured at baseline and end of study. Vital signs and adverse event will be measured at baseline and every follow-up visit including end of study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Bleeding Peptic Ulcers
Keywords
Non-Bleeding Peptic Ulcers, DLBS2411, Ulcer Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment I
Arm Type
Active Comparator
Arm Description
2 Omeprazole capsules 20 mg once daily and 1 placebo caplet of DLBS2411, twice daily
Arm Title
Treatment II
Arm Type
Experimental
Arm Description
1 DLBS2411 caplet 250 mg twice daily and 2 placebo capsules of Omeprazole once daily
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
2 Omeprazole capsules 20 mg, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo caplet of DLBS2411
Other Intervention Name(s)
Placebo caplet of Redacid
Intervention Description
1 placebo caplet of DLBS2411, twice daily
Intervention Type
Drug
Intervention Name(s)
DLBS2411
Other Intervention Name(s)
Redacid
Intervention Description
1 DLBS2411 caplet 250 mg, twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo capsule of Omeprazole
Intervention Description
2 placebo capsules of Omeprazole, once daily
Primary Outcome Measure Information:
Title
Endoscopic ulcer healing rate
Description
Endoscopic ulcer healing rate after 8 weeks of treatment. Ulcer healing rate is defined as the proportion of subjects with complete ulcer-healing (referring to S1 or S2 Scarring stage according to Sakita-Fukutomi classification) as confirmed by endoscopic finding.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The improvement rate of each of gastric symptoms
Description
The improvement rate of each of gastric symptoms at each of the follow-up visits (after 4 and 8 weeks of treatment):
abdominal or epigastric pain (middle or upper stomach)
nausea or vomiting,
bloating
Time Frame
4 and 8 weeks
Title
The quality of ulcer healing
Description
The quality of ulcer healing as measured by the levels of gastric mucosal bFGF (basic fibroblast growth factor) and COX-2 (cyclo-oxygenase), at baseline and Week 8 of treatment.
Time Frame
8 weeks
Title
Mucosal thickness
Description
Gastric mucosal thickness will be measured quantitatively as the expression of MUC5AC by immunohistochemistry (IHC) method, at baseline and Week 8 of treatment.
Time Frame
8 weeks
Title
Patients' global evaluation for their symptoms
Description
Patients' global evaluation for their symptoms categorized as: no improvement or slightly improved or moderately improved or markedly improved, at Week 4 and 8 (end of study).
Time Frame
4 and 8 weeks
Title
Liver function
Description
Liver function (serum ALT (alanine-aminotransferase), serum AST (aspartate-aminotransferase), alkaline phosphatase, total bilirubin) at baseline and at the end of study
Time Frame
8 weeks
Title
Renal function
Description
Renal function (serum creatinine and BUN (blood urea nitrogen) level) at baseline and at the end of study
Time Frame
8 weeks
Title
Adverse events
Description
Adverse event, will be observed throughout the study conduct
Time Frame
4 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IDN Wibawa Prof. DR. Dr., SpPD-KGEH
Organizational Affiliation
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80114
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
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