Gastric pH Regulation in Healthy VolunteersPhase 1/2NCT01573403
Efficacy and Safety of DLBS2411 in Healthy Volunteers
A Phase 1/2 study testing DLBS2411 in people with Gastric pH Regulation in Healthy Volunteers, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as well as its safety in healthy volunteers. DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastric pH Regulation in Healthy Volunteers
- What is being tested?
- DLBS2411
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2012to Jan 2013
- Phase
- Phase 1/2
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects with age of 18-45 years
- Healthy as confirmed by vital signs, clinical and laboratory assessments (normal blood pressure, normal plasma glucose level, normal values of all hematological parameters, adequate liver and renal function)
- BMI 18-25 kg/m2
- Able to take oral medication
Who cannot join
- Gastric pH ≥ 4 at screening
- Currently being an active smoker and suffering from chronic alcoholism
- History of or currently peptic ulcer
- Having clinical diagnosis of Zollinger Ellison syndrome
- Taking any H2RAs, PPIs, antacids, or gastric mucosal protectors within 2 weeks prior to screening
- Taking any other medicines, supplements, or herbals within 3 days prior to screening
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- History of gastro-intestinal disturbances necessitating long-term treatment with any acid suppressing medication, antacids, or gastric mucosal protectors
- The presence of any chronic diseases
- Currently being afflicted by serious infection(s)
- 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 Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital
Jakarta Center, Jakarta Special Capital Region, 10430
About this study
Official title: Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo
This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as well as its safety in healthy volunteers.
DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is hypothetically more potential than PPIs in suppressing gastric acid as our previous preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+ ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.
Read the detailed description
There will be 3 groups of treatment; each group will consist of 18 subjects with the treatment regimens :
- Treatment I : 1 caplet of DLBS2411 250 mg and 1 placebo caplet of DLBS2411, once daily
- Treatment II : 2 caplets of DLBS2411 250 mg, once daily
- Treatment III : 2 placebo caplets of DLBS2411, once daily
Clinical examination to evaluate the investigational drug's efficacy will be performed by a 24-hour-gastric pH monitoring after the first dose of study drug administration. Besides, the pH of the gastric fluid will also be measured at the end of study (Day 3 of treatment). Safety examination will be performed at baseline and at end of study. The occurrence of adverse event will be observed during the study.
All subjects will be under direct supervision of a medical doctor during the study period.
- Being tested
- DLBS2411, Placebo DLBS2411
- Keywords
- Proton pump inhibitor (PPI), DLBS2411, gastric pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS2411Drug
1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily
DLBS2411Drug
2 caplets of DLBS2411 @250 mg, once daily
Placebo DLBS2411Drug
2 placebo caplets of DLBS2411, once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | one dose of DLBS2411 @250 mg Receives: Drug: DLBS2411 |
| Treatment II | Experimental | two doses of DLBS2411 @250 mg Receives: Drug: DLBS2411 |
| Treatment III | Placebo comparator | Not described Receives: Drug: Placebo DLBS2411 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time over 24 hours during which gastric pH is > 4
Percentage of time over 24 hours during which gastric pH is > 4 after a single dose of study medication
Measured: 24 hours
Secondary outcomes (9)
The onset of action
The onset of action, which is defined as time taken to achieve gastric pH of > 4 after the initial dose of study medication
Measured: 24 hours
24-hour median gastric pH
24-hour median gastric pH after the initial dose of study medication
Measured: 24 hours
Gastric pH at the end of study
Gastric pH after a repeated (3-day) dosing of study medication
Measured: 3 days
Change of ECG description from baseline
ECG will be evaluated at baseline (Day 1st)and at end of study (Day 3rd)
Measured: baseline and 3 days after treatment initiation
Routine haematology
Routine haematology (hemoglobin level, hematocrit, erythrocyte count, leucocyte count, differentiation of WBC and platelet count) will be evaluated at baseline and at end of study (Day 3rd)
Measured: Baseline and 3 days after treatment initiation
Liver function
Liver function (ALT, AST, γ-GT, and total bilirubin levels) will be evaluated at baseline and at end of study (Day 3rd)
Measured: baseline and 3 days after treatment initiation
Renal function
Renal function (serum creatinine level) will be evaluated at baseline and at end of study (Day 3rd)
Measured: Baseline and 3 days after treatment initiation
Urinalysis parameters
Urinalysis parameters (urine color, pH, presence of glucose, protein, sediments, epithelial cells, erythrocyte, leucocyte, and others) will be evaluated at baseline and at end of study (Day 3rd)
Measured: Baseline and 3 days after treatment initiation
Adverse events
Type and number of adverse events as well as number of subjects experiencing the events will be observed and evaluated during study period (3 days of treatment)and until the end of study or all adverse events have been recovered or stabilized (which ever comes first).
Measured: 3 days or until all adverse events have been recovered or stabilized (which ever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric pH Regulation in Healthy VolunteersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Murdani Abdullah, Dr., dr., SpPD-KGEH, Principal investigator, Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573403
- Sponsor's protocol ID
- DLBS2411-0111
- Status last verified
- Feb 2013
- First submitted
- 5 Apr 2012
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo
- ClinicalTrials.gov ID
- NCT01573403
- Acronym / sponsor ID
- DLBS2411-0111
- Keywords
- Proton pump inhibitor (PPI), DLBS2411, gastric pH
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Apr 2012 (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 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as well as its safety in healthy volunteers.
DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is hypothetically more potential than PPIs in suppressing gastric acid as our previous preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+ ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.
Detailed description
There will be 3 groups of treatment; each group will consist of 18 subjects with the treatment regimens :
- Treatment I : 1 caplet of DLBS2411 250 mg and 1 placebo caplet of DLBS2411, once daily
- Treatment II : 2 caplets of DLBS2411 250 mg, once daily
- Treatment III : 2 placebo caplets of DLBS2411, once daily
Clinical examination to evaluate the investigational drug's efficacy will be performed by a 24-hour-gastric pH monitoring after the first dose of study drug administration. Besides, the pH of the gastric fluid will also be measured at the end of study (Day 3 of treatment). Safety examination will be performed at baseline and at end of study. The occurrence of adverse event will be observed during the study.
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
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: DLBS2411one dose of DLBS2411 @250 mg |
| Treatment II | Experimental | Drug: DLBS2411two doses of DLBS2411 @250 mg |
| Treatment III | Placebo comparator | Drug: Placebo DLBS2411 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subjects with age of 18-45 years
- Healthy as confirmed by vital signs, clinical and laboratory assessments (normal blood pressure, normal plasma glucose level, normal values of all hematological parameters, adequate liver and renal function)
- BMI 18-25 kg/m2
- Able to take oral medication
Key exclusion criteria (10 listed)
- Gastric pH ≥ 4 at screening
- Currently being an active smoker and suffering from chronic alcoholism
- History of or currently peptic ulcer
- Having clinical diagnosis of Zollinger Ellison syndrome
- Taking any H2RAs, PPIs, antacids, or gastric mucosal protectors within 2 weeks prior to screening
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 |
|---|---|---|
| DLBS24111 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily | Drug | Treatment 1 |
| DLBS24112 caplets of DLBS2411 @250 mg, once daily | Drug | Treatment II |
| Placebo DLBS24112 placebo caplets of DLBS2411, once daily | Drug | Treatment III |
Primary outcome
Percentage of time over 24 hours during which gastric pH is > 4
Time frame: 24 hours
Percentage of time over 24 hours during which gastric pH is > 4 after a single dose of study medication
9 secondary outcomes
The onset of action
Time frame: 24 hours
24-hour median gastric pH
Time frame: 24 hours
Gastric pH at the end of study
Time frame: 3 days
Change of ECG description from baseline
Time frame: baseline and 3 days after treatment initiation
Routine haematology
Time frame: Baseline and 3 days after treatment initiation
Liver function
Time frame: baseline and 3 days after treatment initiation
Renal function
Time frame: Baseline and 3 days after treatment initiation
Urinalysis parameters
Time frame: Baseline and 3 days after treatment initiation
Adverse events
Time frame: 3 days or until all adverse events have been recovered or stabilized (which ever comes first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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.
Murdani Abdullah, Dr., dr., SpPD-KGEH principal investigator
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DLBS2411 in people with Gastric pH Regulation in Healthy Volunteers, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 13 Feb 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of time over 24 hours during which gastric pH is > 4 (time frame: 24 hours). 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 13 Feb 2013.