Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-30 @ 3:46 AM
Study NCT ID:
NCT01573403
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of DLBS2411 in Healthy Volunteers
Sponsor:
Dexa Medica Group
Organization:
Study Overview
Official Title:
Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: