NCT01573403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

April 5, 2012

Last Update Submit

February 12, 2013

Conditions

Gastric pH Regulation in Healthy Volunteers

Keywords

Proton pump inhibitor (PPI)DLBS2411gastric pH

Outcome Measures

Primary Outcomes (1)

  • Percentage of time over 24 hours during which gastric pH is > 4

    Percentage of time over 24 hours during which gastric pH is \> 4 after a single dose of study medication

    24 hours

Secondary Outcomes (9)

  • The onset of action

    24 hours

  • 24-hour median gastric pH

    24 hours

  • Gastric pH at the end of study

    3 days

  • Change of ECG description from baseline

    baseline and 3 days after treatment initiation

  • Routine haematology

    Baseline and 3 days after treatment initiation

  • +4 more secondary outcomes

Study Arms (3)

Treatment 1

EXPERIMENTAL

one dose of DLBS2411 @250 mg

Drug: DLBS2411

Treatment II

EXPERIMENTAL

two doses of DLBS2411 @250 mg

Drug: DLBS2411

Treatment III

PLACEBO COMPARATOR
Drug: Placebo DLBS2411

Interventions

DLBS2411DRUG

1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily

Treatment 1
Placebo DLBS2411DRUG

2 placebo caplets of DLBS2411, once daily

Treatment III

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital

Jakarta Center, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 9, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

ID(1)