Clinical trial NCT01005719: Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)
Official title: Randomized, Crossover, Pharmacodynamic Study Comparing the Effects of Two Proton Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Experimentation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Treatment dose to 4-hr post-dose on Day 7
Secondary outcomes:
measure: 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
timeFrame: Treatment dose to 4-hr post-dose on Day 1
measure: 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
timeFrame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
measure: Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period
timeFrame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
measure: Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7
timeFrame: Treatment dose to 4 hours Post-dose on Day 7
measure: Median 24-hr Intragastric pH on Day 7
timeFrame: Treatment dose to 24-hour post-dose on Day 7
measure: Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7
timeFrame: Treatment dose to 24-hour post-dose on Day 7
measure: Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7
timeFrame: Treatment dose to 24-hours post-dose on Day 7
measure: Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7
timeFrame: Treatment dose to 24-hour post-dose on Day 7
measure: Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7
timeFrame: Treatment dose to 24-hour post-dose on Day 7
measure: Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7
timeFrame: Treatment dose to 24-hour post-dose on Day 7
measure: Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7
timeFrame: Treatment dose to 2-hours post-dose on Day 7
measure: Time to Onset of Inhibition of Acid Secretion on Day 1
timeFrame: Treatment dose to onset of event on Day 1
measure: Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1
timeFrame: Treatment dose to 24-hr post-dose on Day 1
measure: Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1
timeFrame: Treatment dose to 24-hr post-dose on Day 1
measure: Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1
timeFrame: Treatment dose to 24-hour post-dose on Day 1
measure: Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1
timeFrame: Treatment dose to 4-hours post-dose on Day 1
measure: Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing
timeFrame: Treatment dose to event on Day 1 and Day 7
Other outcomes:
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