Clinical trial NCT01573403: Efficacy and Safety of DLBS2411 in Healthy Volunteers
Official title: Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric pH Regulation in Healthy Volunteers
Keywords: Proton pump inhibitor (PPI)
DLBS2411
gastric pH
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2012-04-09
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Percentage of time over 24 hours during which gastric pH is > 4
timeFrame: 24 hours
Secondary outcomes:
measure: The onset of action
timeFrame: 24 hours
measure: 24-hour median gastric pH
timeFrame: 24 hours
measure: Gastric pH at the end of study
timeFrame: 3 days
measure: Change of ECG description from baseline
timeFrame: baseline and 3 days after treatment initiation
measure: Routine haematology
timeFrame: Baseline and 3 days after treatment initiation
measure: Liver function
timeFrame: baseline and 3 days after treatment initiation
measure: Renal function
timeFrame: Baseline and 3 days after treatment initiation
measure: Urinalysis parameters
timeFrame: Baseline and 3 days after treatment initiation
measure: Adverse events
timeFrame: 3 days or until all adverse events have been recovered or stabilized (which ever comes first)
Other outcomes:
Locations:
city: Jakarta Center
country: Indonesia
facility: Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
affiliation: Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta Indonesia
name: Murdani Abdullah, Dr., dr., SpPD-KGEH
role: PRINCIPAL_INVESTIGATOR
References: