Active Control, Double-blind, Double-dummy, Parallel-group, Randomized Study to Assess the Effect of VECAM 40/300, Administered at Bedtime, vs. Esomeprazole 20 mg, Administered 30-60 Min. Before Dinner, on Daytime and Nighttime GERD Symptoms

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 including:
• •Acute gastrointestinal bleeding. or history of GI bleeding within 6 months prior to randomization
• •Zollinger Ellison Syndrome or Gastric hypersecretory condition
• •Esophageal stricture
• •Active gastric or duodenal ulcers within 30 days prior to randomization
• •Gastric outlet obstruction
• •Gastro-paresis or gastric emptying disorder
• •Significant hepatic disease: cirrhosis or hepatic encephalopathy
• •Any significant medical co-morbidity that precludes participation in the study or can affect acid secretion, or sleep as judged by the investigator
• •Significant laboratory abnormalities as determined by the principal investigator.
• •Known metabolic alkalosis, hypocalcemia, sodium restricted diet, hypokalemia, or respiratory alkalosis.
• •Had been treated with any investigational drug or therapy or participated in a clinical trial within 30 days prior to entering the trial.
• •Active or illicit drug or alcohol abuse
• •Use of any medication that alters gastric acid secretion other than the study medications provided by the study personnel.
• •Regular use (\>3 doses per week) of non-steroidal anti-inflammatory drugs (NSAIDs), including COX 2 inhibitors within 30 days prior to randomization or during the study.
• •Use of the following medications during the study:
• •* Bismuth-containing products
• •* Antibiotics
• •* Sucralfate
• •* Misoprostol
• •* Corticosteroids
• •* Prokinetic agents
• •* Anticoagulant therapy
• •* Antiseizure medications
• •* Psychotropic medications
• •* Narcotic medications
• •* Bisphosphonates
• •* Anti-neoplastic treatments
• •* Use of sleep medications:
• •* First generation antihistamines
• •* Benzodiazepines
• •* Modified cyclic antidepressants
• •* Antianxiety medications
• •* Unless dose remains unchanged throughout the study, drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with CNS effects that could mask perception of symptoms (e.g., SSRIs\*, SNRIs\*\*).
• •* Unless consumed during the screening period per protocol instructions:
• •* Proton pump inhibitors (other than the study medication)
• •* Histamine (H2) receptor antagonists
• •Any conditions other than GERD that could be the primary cause of significant sleep disturbances (including but not limited to anxiety, depression, panic attacks, sleep apnea, chronic obstructive pulmonary disease requiring oxygen therapy or that are known to disrupt patients sleep, chronic insomnia, excessive use of caffeine), nocturnal urination
• •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
• •Significant drug allergy or known hypersensitivity to: any proton pump inhibitor drug , or ingredients in the study medications (Omeprazole, Succinic Acid) or their inactive ingredients contained in their capsule, or to Gelusil® tablets
• •Had donated blood within 30 days of entering the trial
• •Known positive serology for HBV, HCV or HIV
• •Diabetes
• •Any reason that makes the patient a poor candidate based on the study physician, or PI's discretion.