Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.
Eligible H. pylori negative, normal gastric acid secreting, healthy volunteers will be treated by the study medications in a randomized, open-label, cross-over study.Up to 60 volunteers may be enrolled to ensure that at least 30 subjects will complete all the study treatments. Omeprazole 20 mg will be administered before breakfast. Vecam 40/300 and Vecam 20/300 will be administered at bedtime w/o food. 24-hour gastric pH will be measured after the fifth dose (day 5).Following screening procedures, subjects will be randomly assigned to receive the different treatments.
All pH measurements will be done in the study center under supervised conditions. All drug administrations will be supervised.
This study is part of the Vecam clinical development plan.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole 20 mg | Active Comparator |
| |
| Vecam 20/300 | Experimental |
| |
| Vecam 40/300 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 20 mg capsule, orally, once daily (before breakfast) for 5 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose. | 5 days | |
| To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast, calculated as percent time gastric pH ≥4 for the 24-hour interval after the fifth dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
BMI > 40
Slow or poor Omeprazole metabolizers (heterozygous or homozygous, respectively) based on CYP2C19 genotyping test.
Any significant history of / or concurrent gastrointestinal diseases or conditions such as:
Significant medical history or concurrent illness as determined by the principal investigator
Any medical disorder that alters the normal gastric acid secretion profile as determined by the principal investigator
History of diabetes mellitus
Significant laboratory abnormalities as determined by the principal investigator
Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia, respiratory alkalosis
Pregnant or lactating women
Had been treated with any investigational drug or therapy or participated in a clinical trial within 30 days prior to entering the trial
Use of any medication other than contraception or hormone replacement therapy; OTC drugs other than vitamins or occasional acetaminophen within 30 days prior to entering the trial or during the trial
Use of NSAID medications within 30 days prior to entering the trial (e.g. Ibuprofen, Aspirin, Naproxen etc)
Positive urine test for alcohol or other drugs
Concurrent use of gastric anti-secretory drugs such as defined below:
Use of any medication that modifies gastric acid secretion 30 days prior to or during the trial.
Had ingested grapefruit within 14 days of dose administration in any trial period
Significant drug allergy or known hypersensitivity to any of the ingredients in the trial drugs Omeprazole, Succinic Acid or to Lidocaine
Consumption of coffee within 48 hours of dose administration in any trial period.
Had donated blood within 30 days of entering the trial
Known positive serology for HBV, HCV or HIV
Any reason which makes the subject a poor candidate based on the physician's discretion
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vijayalakshmi S Pratha, MD | Clinical Applications Laboratories Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Applications Laboratories Inc. | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22372795 | Derived | Chowers Y, Atarot T, Pratha VS, Fass R. The effect of once daily omeprazole and succinic acid (VECAM) vs once daily omeprazole on 24-h intragastric pH. Neurogastroenterol Motil. 2012 May;24(5):426-31, e208-9. doi: 10.1111/j.1365-2982.2012.01884.x. Epub 2012 Feb 28. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vecam |
| Drug |
1 capsule, orally, once daily at bedtime for 5 days. |
|
| Vecam | Drug | 1 capsule, orally, once daily at bedtime for 5 days. |
|
| 5 days |
| To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Vecam 20/300 administered at bedtime w/o food calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose. | 5 days |
| To assess whether Vecam 40/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose | 5 days |
| To assess whether Vecam 20/300 administered at bedtime w/o food is pharmacodynamically superior to Omeprazole 20 mg administered before breakfast calculated as percent time gastric pH ≥4 during nocturnal hours after the fifth dose. | 5 days |
| To asses Vecam 40/300 administered at bedtime w/o food vs. Omeprazole 20 mg administered before breakfast calculated as percent time pH ≥4 during 24-hour interval and nocturnal hours at early dosing days. | 5 days |
| To assess the safety of Vecam 40/300 and Vecam 20/300 administered at bedtime vs. Omeprazole 20 mg administered before breakfast during treatment period. | 5 days |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |