Non-Bleeding Peptic UlcersPhase 3NCT02262169
DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
A Phase 3 study testing Omeprazole and DLBS2411 in people with Non-Bleeding Peptic Ulcers, run by Dexa Medica Group at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Bleeding Peptic Ulcers
- What is being tested?
- Omeprazole and DLBS2411
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2014to Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
Denpasar, Bali, 80114
About this study
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.
Read the 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.
- Conditions
- Non-Bleeding Peptic Ulcers
- Being tested
- Omeprazole, Placebo caplet of DLBS2411, DLBS2411, Placebo capsule of Omeprazole
- Keywords
- Non-Bleeding Peptic Ulcers, DLBS2411, Ulcer Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
2 Omeprazole capsules 20 mg, once daily
Placebo caplet of DLBS2411Drug
Also called Placebo caplet of Redacid
1 placebo caplet of DLBS2411, twice daily
DLBS2411Drug
Also called Redacid
1 DLBS2411 caplet 250 mg, twice daily
Placebo capsule of OmeprazoleDrug
2 placebo capsules of Omeprazole, once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment I | Active comparator | 2 Omeprazole capsules 20 mg once daily and 1 placebo caplet of DLBS2411, twice daily Receives: Drug: Omeprazole; Drug: Placebo caplet of DLBS2411 |
| Treatment II | Experimental | 1 DLBS2411 caplet 250 mg twice daily and 2 placebo capsules of Omeprazole once daily Receives: Drug: DLBS2411; Drug: Placebo capsule of Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (7)
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
Measured: 4 and 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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).
Measured: 4 and 8 weeks
Liver function
Liver function (serum ALT (alanine-aminotransferase), serum AST (aspartate-aminotransferase), alkaline phosphatase, total bilirubin) at baseline and at the end of study
Measured: 8 weeks
Renal function
Renal function (serum creatinine and BUN (blood urea nitrogen) level) at baseline and at the end of study
Measured: 8 weeks
Adverse events
Adverse event, will be observed throughout the study conduct
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2019
- Study completionMar 2019
Why it stopped: This study was terminated due to internal technical issues at study site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Bleeding Peptic UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- IDN Wibawa Prof. DR. Dr., SpPD-KGEH, Principal investigator, Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262169
- Sponsor's protocol ID
- DLBS2411-0313
- Status last verified
- Jul 2019
- First submitted
- 7 Oct 2014
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
- ClinicalTrials.gov ID
- NCT02262169
- Acronym / sponsor ID
- DLBS2411-0313
- Conditions
- Non-Bleeding Peptic Ulcers
- Keywords
- Non-Bleeding Peptic Ulcers, DLBS2411, Ulcer Healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to internal technical issues at study site
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment I | Active comparator | Drug: Omeprazole, Drug: Placebo caplet of DLBS24112 Omeprazole capsules 20 mg once daily and 1 placebo caplet of DLBS2411, twice daily |
| Treatment II | Experimental | Drug: DLBS2411, Drug: Placebo capsule of Omeprazole1 DLBS2411 caplet 250 mg twice daily and 2 placebo capsules of Omeprazole once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged 18-75 years old.
- Diagnosed as non-bleeding peptic ulcers who do not require endoscopic therapy, as confirmed by :
- Subjects with low-risk of recurrent bleeding, defined as both:
- Able to take oral medication.
Key exclusion criteria (15 listed)
- For females of childbearing potential: pregnancy, breast-feeding, the intention of becoming pregnant during the study participation.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeprazole2 Omeprazole capsules 20 mg, once daily | Drug | Treatment I |
| Placebo caplet of DLBS2411Also: Placebo caplet of Redacid1 placebo caplet of DLBS2411, twice daily | Drug | Treatment I |
| DLBS2411Also: Redacid1 DLBS2411 caplet 250 mg, twice daily | Drug | Treatment II |
| Placebo capsule of Omeprazole2 placebo capsules of Omeprazole, once daily | Drug | Treatment II |
Primary outcome
Endoscopic ulcer healing rate
Time frame: 8 weeks
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.
7 secondary outcomes
The improvement rate of each of gastric symptoms
Time frame: 4 and 8 weeks
The quality of ulcer healing
Time frame: 8 weeks
Mucosal thickness
Time frame: 8 weeks
Patients' global evaluation for their symptoms
Time frame: 4 and 8 weeks
Liver function
Time frame: 8 weeks
Renal function
Time frame: 8 weeks
Adverse events
Time frame: 4 and 8 weeks
Results and safety
The study was stopped early (reason given: This study was terminated due to internal technical issues at study site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IDN Wibawa Prof. DR. Dr., SpPD-KGEH principal investigator
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omeprazole and DLBS2411 in people with Non-Bleeding Peptic Ulcers, run by Dexa Medica Group at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was terminated due to internal technical issues at study site). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic ulcer healing rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.