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

NCT ID: NCT01005719

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-01-31

Brief Summary

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

Conditions

Human Experimentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zegerid

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.

Group Type: EXPERIMENTAL

Zegerid

Intervention Type: DRUG

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

Prevacid®

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.

Group Type: ACTIVE_COMPARATOR

Prevacid®

Intervention Type: DRUG

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

No treatment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zegerid

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

Intervention Type: DRUG

Prevacid®

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

Intervention Type: DRUG

Other Intervention Names

omeprazole/sodium bicarbonate, SCH 900934; lansoprazole

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CL2008-18

Identifier Type: -

Identifier Source: secondary_id

P07815

Identifier Type: OTHER

Identifier Source: secondary_id

18135

Identifier Type: -

Identifier Source: org_study_id