Efficacy and Safety of DLBS2411 in Healthy Volunteers
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.
|Gastric pH Regulation in Healthy Volunteers||Drug: DLBS2411 Drug: Placebo DLBS2411||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo|
- 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
- The onset of action [ Time Frame: 24 hours ]The onset of action, which is defined as time taken to achieve gastric pH of > 4 after the initial dose of study medication
- 24-hour median gastric pH [ Time Frame: 24 hours ]24-hour median gastric pH after the initial dose of study medication
- Gastric pH at the end of study [ Time Frame: 3 days ]Gastric pH after a repeated (3-day) dosing of study medication
- Change of ECG description from baseline [ Time Frame: baseline and 3 days after treatment initiation ]ECG will be evaluated at baseline (Day 1st)and at end of study (Day 3rd)
- Routine haematology [ Time Frame: Baseline and 3 days after treatment initiation ]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)
- Liver function [ Time Frame: baseline and 3 days after treatment initiation ]Liver function (ALT, AST, γ-GT, and total bilirubin levels) will be evaluated at baseline and at end of study (Day 3rd)
- Renal function [ Time Frame: Baseline and 3 days after treatment initiation ]Renal function (serum creatinine level) will be evaluated at baseline and at end of study (Day 3rd)
- Urinalysis parameters [ Time Frame: Baseline and 3 days after treatment initiation ]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)
- Adverse events [ Time Frame: 3 days or until all adverse events have been recovered or stabilized (which ever comes first) ]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).
|Study Start Date:||April 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment 1
one dose of DLBS2411 @250 mg
1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily
Experimental: Treatment II
two doses of DLBS2411 @250 mg
2 caplets of DLBS2411 @250 mg, once daily
|Placebo Comparator: Treatment III||
Drug: Placebo DLBS2411
2 placebo caplets of DLBS2411, once daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573403
|Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital|
|Jakarta Center, Jakarta, Indonesia, 10430|
|Principal Investigator:||Murdani Abdullah, Dr., dr., SpPD-KGEH||Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta Indonesia|