Gastroesophageal Reflux Disease (GERD)Phase 3NCT03367195
Efficacy and Safety of DLBS2411 in the Management of GERD
A Phase 3 study testing Omeprazole and DLBS2411 in people with Gastroesophageal Reflux Disease (GERD), run by Dexa Medica Group at 5 sites in Indonesia.
Trial summary
This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice daily, given before morning and evening meals, for an 8-week course of therapy. Subjects should avoid taking meals 2-3 hours before bedtime. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- 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
- 5 sitesIndonesia
- Study dates
- 16 Aug 2018to 9 Sep 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to participate in the study under signed informed consent.
- Male or female subjects aged 18-65 years old.
- Subjects with diagnosis of GERD confirmed by endoscopy, with esophagitis grade A-B according to the LA Classification.
- Able to take oral medication.
- Subjects or subjects' legally acceptable representatives are able and willing to record adverse events in diary.
- Subjects or subjects' legally acceptable representatives have the ability to comply with the trial protocol, including instruction for taking trial medication.
Who cannot join
- For females of childbearing potential: pregnancy and breast-feeding.
- Patients must accept pregnancy tests during the trial if menstrual cycle is missed
- Fertile patients must use a reliable and effective contraceptive
- Subjects with Zollinger Ellison syndrome or peptic ulcer diseases.
- History or current evidence of Barrett's esophagus, esophageal strictures, odynophagia, pyloric stenosis, esophageal motility disorders (such as achalasia, scleroderma), anatomic esophageal abnormality (such as large hiatal hernia), pill-induced esophagitis.
- Helicobacter pylori positive as confirmed by urea breath test (UBT).
Show all 16Show fewer
- History of esophageal, gastric or intestinal surgery including vagotomy.
- Presence of comorbid diseases, such as symptomatic coronary artery disease (CAD) or cardiovascular disease, pulmonary disease (including asthma), hemostasis disorder, pancreatitis, malabsorption, or inflammatory bowel disease, and any other chronic diseases (including chronic cough, laryngitis), any serious infection(s), or malignancy(ies).
- Inadequate liver function defined as ALT or alkaline phosphatase > 2.5 times upper limit of normal.
- Inadequate renal function defined as estimated Glomerular Filtration Rate (eGFR) < 60 mL/min.
- Taking any proton pump inhibitors (PPIs) or sucralfate within 14 days prior to screening.
- Requiring regular and chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, aspirin, anticholinergics, cholinergics, spasmolytics, or opiates, misoprostol or prokinetics.
- Hypersensitivity to proton pump inhibitors.
- Subjects with chronic alcoholism (>40 g alcohol/day) or drug abuse.
- Active heavy smokers (i.e. consuming >10 cigarettes per day).
- Participation in any other clinical studies within 30 days prior to screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Indonesia5 sites
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Padjajaran Dr. Hasan Sadikin Hospital
Bandung
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital
Jakarta, 10430
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital
Semarang
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital
Surabaya
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital
Yogyakarta
About this study
Official title: Efficacy and Safety of DLBS2411 Compared to Omeprazole in the Management of Gastroesophageal Reflux Disease (GERD)
This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice daily, given before morning and evening meals, for an 8-week course of therapy. Subjects should avoid taking meals 2-3 hours before bedtime.
The bioactive fraction of DLBS2411 has been proved 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 cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation.
Recent study of DLBS2411 which was conducted 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 patients with gastric acid disorders such as in gastroesophageal reflux disease (GERD).
Read the detailed description
There will be 2 groups of treatment; each group will consist of 129 subjects with the treatment regimens for 8 weeks:
Treatment I : 1 capsule of Omeprazole 20 mg and 1 placebo caplet of DLBS2411, twice daily Treatment II : 1 caplet of DLBS2411 250 mg and 1 placebo capsule of omeprazole, twice daily
Each study medication will be administered twice daily, 30 minutes before morning (the first) and evening (the last) meals.
The eligible subjects will be randomly allocated to receive study medication (Treatment 1 or Treatment 2) for 8 weeks of treatment, in a double blind fashion. They will be asked to come to the clinic every 4-week interval throughout the study period. Treatment Group 1 will receive Omeprazole twice daily and Placebo DLBS2411 twice daily. While Treatment Group 2 will receive DLBS2411 twice daily and Placebo Omeprazole twice daily.
Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over the 8-week course of therapy. Throughout the 8-week therapy, subjects should record the frequency (presence and absence) of each of GERD symptoms (heartburn, regurgitation, epigastric pain, nausea) daily in the provided Patient's Diary. The severity of each symptom experienced should also be self-evaluated and recorded.
The safety profile of study medication other than vital signs and adverse event will be measured at baseline and end of study.
Along the study, subjects should avoid taking meals 2-3 hours before bedtime. All subjects will be under direct supervision of a medical doctor during the study period.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Omeprazole, DLBS2411, Placebo capsule of Omeprazole, Placebo caplet of DLBS2411
- Keywords
- GERD, DLBS2411, omeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
1 Omeprazole 20 mg capsules twice daily
DLBS2411Drug
Also called Redacid
1 DLBS2411 caplet 250 mg, twice daily
Placebo capsule of OmeprazoleDrug
1 placebo capsule of omeprazole, twice daily
Placebo caplet of DLBS2411Drug
Also called Placebo caplet of Redacid
1 placebo caplet of DLBS2411, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Active comparator | 1 Omeprazole capsule 20 mg and 1 placebo caplet of DLBS2411, twice daily Receives: Drug: Omeprazole; Drug: Placebo caplet of DLBS2411 |
| Treatment II | Experimental | 1 DLBS2411 caplet 250 mg and 1 placebo capsule of Omeprazole, twice 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.
Healing rate by endoscopy
Healing rate is defined as proportion of subjects with either complete or achieving lower endoscopic grade of esophagitis (according to the Los Angeles (LA) classification) at Week 8 (end of study).
Measured: 8 weeks
Secondary outcomes (10)
Changes in GERD Questionnaire (GERDQ) sum scores
Changes in GERDQ sum scores from baseline to Week 4 and Week 8 of treatment.
Measured: 4 and 8 weeks
Composite heartburn and regurgitation response rate
Composite heartburn and regurgitation response rate: defined as proportion of subjects with neither heartburn nor acid regurgitation during the last 7 days (complete resolution of heartburn and acid regurgitation) by Week 4 and Week 8.
Measured: 4 and 8 weeks
Heartburn response rate
Heartburn response rate: defined as proportion of subjects with no heartburn during the last 7 days (complete resolution of heartburn) by Week 4 and Week 8 (end of study).
Measured: 4 and 8 weeks
Regurgitation response rate
Regurgitation response rate: defined as proportion of subjects with no regurgitation during the last 7 days (complete resolution of regurgitation) by Week 4 and Week 8 (end of study).
Measured: 4 and 8 weeks
Overall response rate
Overall response rate: defined as proportion of subjects with controlled GERD symptoms by Week 4 and 8 of treatment, defined as proportion categorized as:
- complete relief (no GERD symptoms during the last 7-day);
- partial relief (a decrease in frequency but not complete relief of GERD symptoms during the last 7-day); and
- no response (increase or no change in frequency of GERD symptoms).
Measured: 4 and 8 weeks
Vital sign
Vital sign (blood pressure) from baseline to every follow-up visit including end of study
Measured: 4 and 8 weeks
Electrocardiography (ECG)
Electrocardiography (ECG) at baseline and at the end of study
Measured: 8 weeks
Liver function
Liver function (serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin)from baseline to every follow-up visit including end of study
Measured: 4 and 8 weeks
Renal function
Renal function (serum creatinine and blood urea nitrogen (BUN) level) from baseline to every follow-up visit including end of study
Measured: 4 and 8 weeks
Adverse event
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 posted8 Dec 2017
- Study start16 Aug 2018
- Primary completion4 May 2020
- Study completion9 Sep 2020
Why it stopped: Very low recruitment rate. The Study Site classifies as tertiary referral hospital. Therefore, GERD Patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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
- Dadang Makmun, SpPD, KGEH, Principal investigator, Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta IndonesiaIswan A. Nusi, Prof. KGEH, FINASIM, FACG, Principal investigator, Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital, Surabaya, IndonesiaPutut Bayupurnama, SpPD, KGEH, Principal investigator, Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital, Yogyakarta, IndonesiaHery D. Purnomo, SpPD, KGEH, Principal investigator, Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Diponegoro Dr. Kariadi Hospital, Semarang, IndonesiaDolvy Girawan, M. Kes., SpPD, KGEH, Principal investigator, Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Padjajaran Dr. Hasan Sadikin Hospital, Bandung, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367195
- Sponsor's protocol ID
- DLBS2411-0213
- Status last verified
- Jan 2021
- First submitted
- 27 Nov 2017
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of DLBS2411 Compared to Omeprazole in the Management of Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT03367195
- Acronym / sponsor ID
- DLBS2411-0213
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, DLBS2411, omeprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very low recruitment rate. The Study Site classifies as tertiary referral hospital. Therefore, GERD Patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 8 Dec 2017 (actual)
- 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 comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice daily, given before morning and evening meals, for an 8-week course of therapy. Subjects should avoid taking meals 2-3 hours before bedtime.
The bioactive fraction of DLBS2411 has been proved 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 cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation.
Recent study of DLBS2411 which was conducted 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 patients with gastric acid disorders such as in gastroesophageal reflux disease (GERD).
Detailed description
There will be 2 groups of treatment; each group will consist of 129 subjects with the treatment regimens for 8 weeks:
Treatment I : 1 capsule of Omeprazole 20 mg and 1 placebo caplet of DLBS2411, twice daily Treatment II : 1 caplet of DLBS2411 250 mg and 1 placebo capsule of omeprazole, twice daily
Each study medication will be administered twice daily, 30 minutes before morning (the first) and evening (the last) meals.
The eligible subjects will be randomly allocated to receive study medication (Treatment 1 or Treatment 2) for 8 weeks of treatment, in a double blind fashion. They will be asked to come to the clinic every 4-week interval throughout the study period. Treatment Group 1 will receive Omeprazole twice daily and Placebo DLBS2411 twice daily. While Treatment Group 2 will receive DLBS2411 twice daily and Placebo Omeprazole twice daily.
Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over the 8-week course of therapy. Throughout the 8-week therapy, subjects should record the frequency (presence and absence) of each of GERD symptoms (heartburn, regurgitation, epigastric pain, nausea) daily in the provided Patient's Diary. The severity of each symptom experienced should also be self-evaluated and recorded.
The safety profile of study medication other than vital signs and adverse event will be measured at baseline and end of study.
Along the study, subjects should avoid taking meals 2-3 hours before bedtime. All subjects will be under direct supervision of a medical doctor during the study period.
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 1 | Active comparator | Drug: Omeprazole, Drug: Placebo caplet of DLBS24111 Omeprazole capsule 20 mg and 1 placebo caplet of DLBS2411, twice daily |
| Treatment II | Experimental | Drug: DLBS2411, Drug: Placebo capsule of Omeprazole1 DLBS2411 caplet 250 mg and 1 placebo capsule of Omeprazole, twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agree to participate in the study under signed informed consent.
- Male or female subjects aged 18-65 years old.
- Subjects with diagnosis of GERD confirmed by endoscopy, with esophagitis grade A-B according to the LA Classification.
- Able to take oral medication.
- Subjects or subjects' legally acceptable representatives are able and willing to record adverse events in diary.
Key exclusion criteria (16 listed)
- For females of childbearing potential: pregnancy and breast-feeding.
- Subjects with Zollinger Ellison syndrome or peptic ulcer diseases.
- History or current evidence of Barrett's esophagus, esophageal strictures, odynophagia, pyloric stenosis, esophageal motility disorders (such as achalasia, scleroderma), anatomic esophageal abnormality (such as large hiatal hernia), pill-induced esophagitis.
- Helicobacter pylori positive as confirmed by urea breath test (UBT).
- History of esophageal, gastric or intestinal surgery including vagotomy.
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 |
|---|---|---|
| Omeprazole1 Omeprazole 20 mg capsules twice daily | Drug | Treatment 1 |
| DLBS2411Also: Redacid1 DLBS2411 caplet 250 mg, twice daily | Drug | Treatment II |
| Placebo capsule of Omeprazole1 placebo capsule of omeprazole, twice daily | Drug | Treatment II |
| Placebo caplet of DLBS2411Also: Placebo caplet of Redacid1 placebo caplet of DLBS2411, twice daily | Drug | Treatment 1 |
Primary outcome
Healing rate by endoscopy
Time frame: 8 weeks
Healing rate is defined as proportion of subjects with either complete or achieving lower endoscopic grade of esophagitis (according to the Los Angeles (LA) classification) at Week 8 (end of study).
10 secondary outcomes
Changes in GERD Questionnaire (GERDQ) sum scores
Time frame: 4 and 8 weeks
Composite heartburn and regurgitation response rate
Time frame: 4 and 8 weeks
Heartburn response rate
Time frame: 4 and 8 weeks
Regurgitation response rate
Time frame: 4 and 8 weeks
Overall response rate
Time frame: 4 and 8 weeks
Vital sign
Time frame: 4 and 8 weeks
Electrocardiography (ECG)
Time frame: 8 weeks
Liver function
Time frame: 4 and 8 weeks
Renal function
Time frame: 4 and 8 weeks
Adverse event
Time frame: 4 and 8 weeks
Results and safety
The study was stopped early (reason given: Very low recruitment rate. The Study Site classifies as tertiary referral hospital. Therefore, GERD Patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
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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.
Dadang Makmun, SpPD, KGEH principal investigator
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta Indonesia
Iswan A. Nusi, Prof. KGEH, FINASIM, FACG principal investigator
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Airlangga Dr. Soetomo Hospital, Surabaya, Indonesia
Putut Bayupurnama, SpPD, KGEH principal investigator
Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Gadjah Mada Dr. Sardjito Hospital, Yogyakarta, Indonesia
5 sites 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 Gastroesophageal Reflux Disease (GERD), run by Dexa Medica Group at 5 sites 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 6 inclusion and 16 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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: Very low recruitment rate. The Study Site classifies as tertiary referral hospital. Therefore, GERD Patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.). 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?
Healing rate by endoscopy (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 7 Jan 2021.