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

Completed · Phase 2

Conditions studied: Gastroesophageal Reflux

In brief

The study is designed to assess the effect and safety of oral administration of VECAM 40/300 administered at bedtime compared to Esomeprazole 20 mg administered 30-60 minutes before dinner, for control of nighttime and daytime HB and other 24 hour GERD symptoms. The rational for the study is based on the contention that VECAM exhibits potent inhibition of acid secretion and because of its mechanism of action, it can be administered at bedtime without food. Such timing of drug dosing will allow effective inhibition of nighttime acid secretion. Because of its mechanism of action, VECAM exhibits improved 24-hour inhibition of acid secretion and hence, its bedtime administration will not compromise its effect during the daytime. This improved control of acid secretion will predictably result in better control of nighttime as well as daytime heartburn (HB) symptoms.

Key facts

Study ID

NCT01059383

Run by

Vecta Ltd.

People needed

52

Starts

2009-12-01

Expected to finish

2011-06-01

Last updated by the study team

2012-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75 years
• Male or female
• H. pylori negative status
• Suffering from nighttime and daytime heartburn for the last ≥3 months
• At least 28 days of PPI use prior to study entry
• Patients have to be current PPI users with either:
• Category 1): ≥ 2 HB episodes in 7 consecutive days, at least one during the nighttime to approved PPI doses, or
• Category 2): only obtaining complete relief of GERD symptoms following the addition of acid suppressive agents (e.g. H2RA, additional PPI dose), or antacid therapy, to the approved PPI dose.
• Reporting of ≥ 3 HB episodes in 7 consecutive days, at least two during the nighttime, w/o medical treatment during a screening period of up to 21 days (report is based on a daily diary during the screening period) and for Category 1 patients, at least one more HB episode as compared to single dose treatment period.
• Use of acceptable form of birth control in females with child-bearing potential
• Can swallow a size "00" capsule without difficulty
• Willing to comply with study protocol
• Understood and signed an informed consent form for this study

You may not qualify if…

• 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

Where it is running

• Clinical Applications Laboratories Inc. — San Diego, California, United States
• Oklahoma Foundation for Digestive Research — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.