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

Bayer

Status and phase: Completed; Phase 3

Conditions: Human Experimentation

Treatments: Drug: Zegerid; Drug: Prevacid®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005719

P07815 (Other Identifier)

18135

CL2008-18

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Zegerid

Experimental group

Description:

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.

Treatment:

Drug: Zegerid

Prevacid®

Active Comparator group

Description:

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.

Treatment:

Drug: Prevacid®

No treatment

No Intervention group

Description:

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.