Gastric pH Regulation in Healthy Volunteers Clinical Trial
Official title:
Effect of DLBS2411 on Gastric pH Regulation in Healthy Volunteers : Comparison With Placebo
| Verified date | February 2013 |
| Source | Dexa Medica Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Indonesia: National Agency of Drug and Food Control |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | January 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital | Jakarta Center | Jakarta |
| Lead Sponsor | Collaborator |
|---|---|
| Dexa Medica Group |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | The onset of action | The onset of action, which is defined as time taken to achieve gastric pH of > 4 after the initial dose of study medication | 24 hours | No |
| Secondary | 24-hour median gastric pH | 24-hour median gastric pH after the initial dose of study medication | 24 hours | No |
| Secondary | Gastric pH at the end of study | Gastric pH after a repeated (3-day) dosing of study medication | 3 days | No |
| Secondary | Change of ECG description from baseline | ECG will be evaluated at baseline (Day 1st)and at end of study (Day 3rd) | baseline and 3 days after treatment initiation | Yes |
| Secondary | Routine haematology | 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) | Baseline and 3 days after treatment initiation | Yes |
| Secondary | Liver function | Liver function (ALT, AST, ?-GT, and total bilirubin levels) will be evaluated at baseline and at end of study (Day 3rd) | baseline and 3 days after treatment initiation | Yes |
| Secondary | Renal function | Renal function (serum creatinine level) will be evaluated at baseline and at end of study (Day 3rd) | Baseline and 3 days after treatment initiation | Yes |
| Secondary | Urinalysis parameters | 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) | Baseline and 3 days after treatment initiation | Yes |
| Secondary | Adverse events | 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). | 3 days or until all adverse events have been recovered or stabilized (which ever comes first) | Yes |