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

NCT01059383 | Completed Phase 2

• 1 other identifier: VCT007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; GERD; Nocturnal GERD; Heartburn; Nighttime Heartburn

Outcome Measures

Primary Outcomes (1)

• Percentage of days with neither daytime nor nighttime heartburn during week 1, 2, 3, 4 and the overall treatment period measured with a patient-reported HB daily diary

  4 weeks

Secondary Outcomes (2)

• Complete resolution of nighttime and daytime HB during the subject's last 7 diary reported days in the study,

  4 weeks

• Percentage of days without nighttime HB on week 1, 2, 3, 4 and the overall treatment period, measured with a patient-reported HB daily diary.

  4 weeks

Study Arms (2)

VECAM 40/300

EXPERIMENTAL

Drug: VECAM 40/300

Esomeprazole 20 mg

ACTIVE COMPARATOR

Drug: Esomeprazole 20 mg

Interventions

VECAM 40/300 DRUG

1 capsule, orally, once daily at bedtime.

VECAM 40/300

Esomeprazole 20 mg DRUG

1 capsule, orally, once daily 30-60 min. before dinner

Esomeprazole 20 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vecta Ltd.: lead

Study Sites (2)

Clinical Applications Laboratories Inc.

San Diego, California, 92103, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (2)