Efficacy and Safety of DLBS2411 in Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastric pH Regulation in Healthy Volunteers	Drug: DLBS2411 Drug: Placebo DLBS2411	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo

Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:

Percentage of time over 24 hours during which gastric pH is > 4 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Percentage of time over 24 hours during which gastric pH is > 4 after a single dose of study medication

Secondary Outcome Measures:

The onset of action [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
24-hour median gastric pH after the initial dose of study medication
Gastric pH at the end of study [ Time Frame: 3 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
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).

Enrollment:	54
Study Start Date:	April 2012
Study Completion Date:	January 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment 1 one dose of DLBS2411 @250 mg	Drug: DLBS2411 1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily
Experimental: Treatment II two doses of DLBS2411 @250 mg	Drug: DLBS2411 2 caplets of DLBS2411 @250 mg, once daily
Placebo Comparator: Treatment III	Drug: Placebo DLBS2411 2 placebo caplets of DLBS2411, once daily

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573403

Locations

Indonesia
Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital
Jakarta Center, Jakarta, Indonesia, 10430

Sponsors and Collaborators

Dexa Medica Group

Investigators

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

More Information

No publications provided

Responsible Party:	Dexa Medica Group
ClinicalTrials.gov Identifier:	NCT01573403 History of Changes
Other Study ID Numbers:	DLBS2411-0111
Study First Received:	April 5, 2012
Last Updated:	February 12, 2013
Health Authority:	Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:

Proton pump inhibitor (PPI)
DLBS2411
gastric pH

Additional relevant MeSH terms:

Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013