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

Study Overview
=================
Brief Summary
-----------------
This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.

Official Title
-----------------
Randomized, Crossover, Pharmacodynamic Study Comparing the Effects of Two Proton Pump Inhibitors

Conditions
-----------------
Human Experimentation

Intervention / Treatment
-----------------
* Drug: Zegerid
* Drug: Prevacid®


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zegerid<br>Participants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. | Drug: Zegerid<br>* Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.<br>* Other names: omeprazole/sodium bicarbonate, SCH 900934;|
| Active Comparator: Prevacid®<br>Participants receiving Prevacid® (lansoprazole) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. | Drug: Prevacid®<br>* Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.<br>* Other names: lansoprazole;|
| No Intervention: No treatment<br>Participants receiving No treatment in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants took approximately 2 oz of water once daily for 7 days. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Treatment dose to 4-hr post-dose on Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | Treatment dose to 4-hr post-dose on Day 1 and Day 7 | 
| Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing. | Treatment dose to 4-hr post-dose on Day 1 and Day 7 | 
| Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7 |  | Treatment dose to 4 hours Post-dose on Day 7 | 
| Median 24-hr Intragastric pH on Day 7 | The median intragastric pH values were recorded over a 24-hr period. | Treatment dose to 24-hour post-dose on Day 7 | 
| Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7 |  | Treatment dose to 24-hour post-dose on Day 7 | 
| Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7 |  | Treatment dose to 24-hours post-dose on Day 7 | 
| Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7 | Number of participants maintaining intragastric pH > 4 for at least 12 hrs at steady-state on Day 7 | Treatment dose to 24-hour post-dose on Day 7 | 
| Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 | Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at steady-state on Day 7 | Treatment dose to 24-hour post-dose on Day 7 | 
| Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 |  | Treatment dose to 24-hour post-dose on Day 7 | 
| Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 | The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed. | Treatment dose to 2-hours post-dose on Day 7 | 
| Time to Onset of Inhibition of Acid Secretion on Day 1 | The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed. | Treatment dose to onset of event on Day 1 | 
| Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1 |  | Treatment dose to 24-hr post-dose on Day 1 | 
| Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1 |  | Treatment dose to 24-hr post-dose on Day 1 | 
| Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1 |  | Treatment dose to 24-hour post-dose on Day 1 | 
| Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1 |  | Treatment dose to 4-hours post-dose on Day 1 | 
| Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing | The earliest time during the first 4 hours after dosing that the median pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.) | Treatment dose to event on Day 1 and Day 7 |