Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
54 participants
INTERVENTIONAL
2012-04-30
2013-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment 1
one dose of DLBS2411 @250 mg
DLBS2411
1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily
Treatment II
two doses of DLBS2411 @250 mg
DLBS2411
2 caplets of DLBS2411 @250 mg, once daily
Treatment III
Placebo DLBS2411
2 placebo caplets of DLBS2411, once daily
Interventions
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DLBS2411
1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily
DLBS2411
2 caplets of DLBS2411 @250 mg, once daily
Placebo DLBS2411
2 placebo caplets of DLBS2411, once daily
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Dexa Medica Group
INDUSTRY
Responsible Party
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Principal Investigators
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Murdani Abdullah, Dr., dr., SpPD-KGEH
Role: PRINCIPAL_INVESTIGATOR
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta Indonesia
Locations
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Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital
Jakarta Center, Jakarta Special Capital Region, Indonesia
Countries
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Other Identifiers
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DLBS2411-0111
Identifier Type: -
Identifier Source: org_study_id
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