Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)

Bayer63 enrolled

Overview

This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Human Experimentation

Interventions

ZegeridDRUG

Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.

Prevacid®DRUG

Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age. * Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor. * Participants must have normal or clinically acceptable physical exam and ECG. * Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures, or participation. * Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed. Exclusion Criteria: * History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors * History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month. * Positive H. pylori breath test at screening. * Participation in any study of an investigational treatment in the 30 days before Screening or participation in another study at any time during the period of this study * Any significant medical illness that would contraindicate participation in the study * Gastrointestinal disorder or surgery leading to impaired drug absorption * Any significant mental illness, such as schizophrenia or bipolar disorder * History (in the past year) suggestive of alcohol or drug abuse or dependence, or excessive alcohol use (\>2 units per day on average; for example \>2 bottles of beer, \>2 glasses of wine, \>2 ounces of liquor/spirits), or excessive alcohol use during the study * Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion * Currently using or use of any prescription or over the counter (OTC) medications that affect gastrointestinal function, including first generation antihistamines (e.g. diphenhydramine) and anticholinergic agents within 7 days prior to 1st treatment administration. * Currently using, or use within 14 days of first treatment administration, or having a history of frequent use of antacids, OTC or Prescription (Rx) H2 receptor antagonists, or OTC or Rx use of proton pump inhibitors. * Positive urine drug/alcohol test at Screening.

Outcomes

Primary Outcomes

Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7

Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.

Time frame: Treatment dose to 4-hr post-dose on Day 7

Secondary Outcomes

Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1

Time frame: Treatment dose to 4-hr post-dose on Day 1

The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7

Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here.

Time frame: Treatment dose to 4-hr post-dose on Day 1 and Day 7

Data from ClinicalTrials.gov

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